paddy Posted September 9, 2004 Share Posted September 9, 2004 Hi There All, Dave and I went to the Onc. today. He wants to put David on Iressa because he says that the Taxotere has not helped him. David had told me months ago that the Medicair had agreed to cover it, but right there in the Dr's office he told me that they said they "wouldn't" cover it. I really can't believe this as I have been telling everyone how Iressa was considered to be really good for some people etc. etc and hoping that it would do well for Dave. Why didn't Dave say something then!? I can't believe we got our lines so crossed! I cried all the way home, I just couldn't stop. I thought someone said that Medicair was paying for Iressa now, in fact I am sure I read an article to that fact some time ago. The Oncologist also asked whether our girls had been up to see theire Dad and we explained why they hadn't been up, and he hinted that there were cheap air fares etc. I think he was trying to say, (in a kind way,) that time is short. The Oncologist also said that we should not worry about having the colonoscopy which the doctor wanted Dave to have. I agree,- they didn't see any masses etc. Why put the poor man through this proceedure if they can't do anything for him anyway. Exscuse the screed, I just needed to "talk" and there is no one around to talk to at the moment . Thank Goodness for you guys! Paddy Quote Link to comment Share on other sites More sharing options...
Elaine Posted September 9, 2004 Share Posted September 9, 2004 Paddy Let me find the article for you. I know you have to make a special application. I am so sorry, but I am off to look for your needed info and will write more later. elaine Quote Link to comment Share on other sites More sharing options...
Elaine Posted September 9, 2004 Share Posted September 9, 2004 Here it is: http://lchelp.com/community/viewtopic.p ... are+iressa There is a deadline to apply. Maybe you could buy the first thirty days and see if you are selected??? You both are in my thoughts and prayers. And there are still clinical trials being done on Iressa too. Couldn't your Onc try to get David in one of those? elaine Quote Link to comment Share on other sites More sharing options...
stand4hope Posted September 9, 2004 Share Posted September 9, 2004 Oh, Elaine, thank you so much for coming to the rescue. Paddy, you hang in there. I'm at work now and can't stay on here, but I will call you tonight. Love, Peggy Quote Link to comment Share on other sites More sharing options...
paddy Posted September 9, 2004 Author Share Posted September 9, 2004 Thank you so very much Elaine. We will try Medicair again this afternoon armed with this info. My Onc. also gave me an Iressa brochure and we will phone them too. Thanks to you and Peggy for being there, I am pretty devastated by this but I must take some big breaths and calm myself. Love to you both, Paddy PS What a Great couple you make Peggy and What's his Name?! Quote Link to comment Share on other sites More sharing options...
Andrea Posted September 9, 2004 Share Posted September 9, 2004 This just makes me sooooooo gosh darn bahumbug suck a duck mad. I do not understand how life saving drugs are not available to all. I can see (maybe) covering prozac but not paxil b/c they are similar, or allegra and not zyertec. But to not cover Iressa, where there is NOTHING similar is just beyond ridiculous. I asked my oncologist if there are any programs where you can donate Iressa when you are done with it b/c so many cannot afford it if insurance did not pay and I can't really tell what his response was. He just said there are a lot of people who cannot take it who need it, but for now, keep it in the cabinet in case she goes back on it. So maybe there are such programs??????? Quote Link to comment Share on other sites More sharing options...
paddy Posted September 9, 2004 Author Share Posted September 9, 2004 Thank You so much Andrea, As far as I know, the California Law forbids donation of medications. I know I overheard a widower talking to the nurses at the oncoclogist's office about some medication which his wife had not used. She said he could not donate it but he could leave it with them. I wondered what they would do with it! Paddy. Quote Link to comment Share on other sites More sharing options...
Elaine Posted September 9, 2004 Share Posted September 9, 2004 Paddy It is against the law, but there is an underground, so to speak. Some Docs take part in it and most hospices do. elaine Quote Link to comment Share on other sites More sharing options...
Snowflake Posted September 9, 2004 Share Posted September 9, 2004 Paddy, Call them. Apply through the link Elaine has found... Don't accept "No" for an answer. A possible game plan: Take the rest of the week (tomorrow is Friday) off. Digest the news you have received. Accept it. Now move on - first thing Monday morning, call Medicare. Take notes. Note when you call and who you talk to. Ask to speak to a supervisor. Note who you talk to and keep going until someone can help you. Keep track, keep a pad and pen by the phone. Ask the doctor for assistance in getting approval, contact Astra Zeneca about trials in the area (or out, you oncologist could monitor)... Turn into the rest stop and collect yourself, and keep moving. The news is not what you wanted to hear, give yourself a little time to adjust to yet another "new normal" and set your sights on the next battle. Let me know if I can help you in any way. Becky Quote Link to comment Share on other sites More sharing options...
Andrea Posted September 9, 2004 Share Posted September 9, 2004 I can see both sides I guess--no way to make sure donated medicine is not contaminated. But still, if it can save a life. Paddy--another suggestion, you are in LA, not sure where your hubby is treated, but call City of Hope and Cedars Cancer Center and ask them if they ahve any information on how to get patients medication like Iressa when itis not covered. I would thik that such big hospitals would ahve someone to at least answer those kind of questions. Quote Link to comment Share on other sites More sharing options...
Elaine Posted September 9, 2004 Share Posted September 9, 2004 Her ONc's office should have a social worker who should be doing this for her. She can apply directly to the drug company and the social worker will do that. The income guidlines are ridiculous, however. And it is hard to imagine that a drug costing 1,800 a month would require an income of less than 34,000, which I think is the case, if I remember correctly. Paddy, does your onc have social workers on staff? If so call them. elaine Quote Link to comment Share on other sites More sharing options...
john Posted September 9, 2004 Share Posted September 9, 2004 Here is one clinical trial in the LA area. Erlotinib is tarceva http://clinicaltrials.gov/ct/show/NCT00072072?order=5 Quote Link to comment Share on other sites More sharing options...
john Posted September 9, 2004 Share Posted September 9, 2004 You will find 4 more trials in below. I am pretty sure medicare pays for trials. Mom mom was on either medicare or medicaid (she was retired) and my parents bills were always VERY small. Monoclonal Antibody ABX-EGF as Second-Line Therapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer This study is currently recruiting patients. Sponsored by Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) Purpose RATIONALE: Monoclonal antibodies, such as ABX-EGF, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody ABX-EGF as second-line therapy in treating patients who have stage IIIB or stage IV non-small cell lung cancer. Condition Treatment or Intervention Phase recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer Drug: monoclonal antibody ABX-EGF Procedure: antibody therapy Procedure: biological response modifier therapy Procedure: monoclonal antibody therapy Phase II MedlinePlus related topics: Brain Cancer; Cancer; Cancer Alternative Therapy; Lung Cancer; Respiratory Diseases Study Type: Interventional Study Design: Treatment Official Title: Phase II Study of Monoclonal Antibody ABX-EGF as Second-Line Treatment for Patients With Stage IIIB or IV Non-Small Cell Lung Cancer Further Study Details: OBJECTIVES: Primary Determine the response rate (complete or partial response) in patients with stage IIIB or IV non-small cell lung cancer receiving monoclonal antibody ABX-EGF as second-line treatment after failure on prior paclitaxel and carboplatin. Secondary Determine additional measures of clinical efficacy of this drug, including progression-free survival, overall survival, best overall response rate, and time to disease progression, in these patients. Determine the safety of this drug in these patients. Determine the pharmacokinetics of this drug in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive monoclonal antibody ABX-EGF IV over 1 hour once weekly on weeks 1-6. Treatment repeats every 6 weeks for up to 8 courses in the absence of disease progression, unacceptable toxicity, or a human anti-human antibody response. Patients are followed at 4 weeks and then every 3 months for up to 2 years. PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study. Eligibility Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both Criteria DISEASE CHARACTERISTICS: Histologically confirmed non-small cell lung cancer (NSCLC) Stage IIIB with pericardial or pleural effusion Stage IV Unidimensionally measurable disease Lesion must be ≥ 20 mm by CT scan or MRI OR ≥ 10 mm by spiral CT scan Prior radiotherapy to the only site of measurable disease is allowed provided there is progression at that site Failed prior treatment with carboplatin and paclitaxel on treatment arm 1, part 2, of protocol Immunex-054.0004 Documented disease progression within 6 months of the last dose of chemotherapy Brain metastases allowed if controlled and asymptomatic with no medications or radiotherapy within the past week PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy At least 12 weeks Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic AST and ALT ≤ 3 times upper limit of normal (ULN) Bilirubin ≤ 1.5 times ULN Renal Creatinine clearance > 15 mL/min Calcium ≤ ULN (treatment for hypercalcemia is allowed) Cardiovascular LVEF ≥ 45% by MUGA or echocardiogram No myocardial infarction within the past year No symptomatic ventricular arrhythmia No symptomatic conduction abnormality Other HIV negative No hypersensitivity to any ingredients in the study drug No hypersensitivity to Staphylococcus aureus protein A No other malignancy within the past 5 years except basal cell carcinoma or carcinoma in situ of the cervix No chronic medical condition or laboratory abnormality that would preclude study participation No psychiatric illness that would preclude study participation or compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 month after study participation PRIOR CONCURRENT THERAPY: Biologic therapy No prior biologic therapy Chemotherapy See Disease Characteristics No prior chemotherapy except paclitaxel and carboplatin At least 30 days since prior paclitaxel/carboplatin treatment Endocrine therapy Prior steroid therapy for NSCLC allowed At least 1 week since prior steroid therapy for brain metastases Radiotherapy See Disease Characteristics At least 1 week since prior radiotherapy for brain metastases More than 2 weeks since prior radiotherapy No concurrent radiotherapy Concurrent local radiotherapy to bone lesions allowed provided no more than 10% of bone marrow is irradiated and lesions are not being evaluated to assess response Surgery Prior surgery for NSCLC allowed Other No other prior therapy for NSCLC More than 30 days since prior investigational therapy No concurrent antihypercalcemic treatment as cancer therapy for bone disease No other concurrent experimental medications Location and Contact Information California Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, 90095, United States; Recruiting Diane Prager, MD 310-794-7758 Study chairs or principal investigators Diane Prager, MD, Principal Investigator, Jonsson Comprehensive Cancer Center More Information Clinical trial summary from the National Cancer Institute's PDQ® database Study ID Numbers: CDR0000355113; UCLA-0308088; IMMUNEX-054.0008; AMGEN-20025408; ABX-0308 Record last reviewed: February 2004 Record first received: March 8, 2004 ClinicalTrials.gov Identifier: NCT00079209 ClinicalTrials.gov processed this record on 2004-09-09 -------------------------------------------------------------------------------- ABT-751 in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That is Refractory to Taxane Therapy This study is currently recruiting patients. Sponsored by Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) Purpose RATIONALE: Drugs used in chemotherapy, such as ABT-751, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of ABT-751 in treating patients who have stage IIIB or stage IV non-small cell lung cancer that is refractory to taxane therapy (such as paclitaxel or docetaxel). Condition Treatment or Intervention Phase recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer Drug: ABT-751 Procedure: chemotherapy Phase II MedlinePlus related topics: Brain Cancer; Cancer; Cancer Alternative Therapy; Lung Cancer; Respiratory Diseases Study Type: Interventional Study Design: Treatment Official Title: Phase II Study of ABT-751 in Patients With Stage IIIB or IV Non-Small Cell Lung Cancer Refractory to Taxane Therapy Further Study Details: OBJECTIVES: Primary Determine the objective response rate (partial and complete responses) in patients with stage IIIB or IV non-small cell lung cancer refractory to taxane therapy when treated with ABT-751. Secondary Determine the time to progression in patients treated with this drug. Determine the survival of patients treated with this drug. Determine the duration of overall response in patients treated with this drug. Determine the toxic effects of this drug in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive oral ABT-751 once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for up to 2 years. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study. Eligibility Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both Criteria DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer Stage IIIB or IV disease Refractory to at least 2 courses (6 weeks) of prior taxane therapy (e.g., paclitaxel or docetaxel) Disease progression during or within 9 weeks of completing taxane therapy in the adjuvant setting OR during or within 24 weeks of completing taxane therapy in the metastatic setting Measurable disease No known CNS metastasis PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,200/mm^3 Hemoglobin ≥ 9.0 g/dL Platelet count ≥ 100,000/mm^3 Hepatic AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) Bilirubin ≤ 2 mg/dL (3.0 mg/dL if liver metastases are present) Renal Creatinine ≤ 2 mg/dL Cardiovascular No unstable cardiovascular conditions No uncontrolled hypertension No angina No New York Heart Association class III congestive heart failure within the past 6 months No myocardial infarction within the past 6 months Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 2 months after study participation No neurology category findings greater than grade 1 (e.g., paresthesia, deep tendon reflexes, or weakness that is subjective and/or does not interfere with function) No allergy to sulfa medications No other clinically significant medical condition that would preclude study participation No other prior or concurrent malignancies except for the following: Adequately treated carcinoma in situ of the cervix Basal cell or squamous cell skin cancer Prior nonpulmonary malignancy confined and surgically resected with no evidence of disease within the past 3 years PRIOR CONCURRENT THERAPY: Biologic therapy No hematopoietic growth factors given concurrently with study drug Chemotherapy See Disease Characteristics No more than 2 prior chemotherapy regimens Endocrine therapy Not specified Radiotherapy No concurrent radiotherapy Surgery More than 6 months since prior coronary angioplasty or stenting No concurrent surgery Other More than 4 weeks since prior antitumor therapy No more than 1 prior investigational agent given alone or with standard taxane therapy No concurrent colchicine No other concurrent investigational agents No other concurrent anticancer therapy Location and Contact Information California Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, 90095-5907, United States; Recruiting Robert Alan Figlin, MD, FACP 310-825-5788 rfiglin@mednet.ucla.edu Study chairs or principal investigators Robert Alan Figlin, MD, FACP, Principal Investigator, Jonsson Comprehensive Cancer Center More Information Clinical trial summary from the National Cancer Institute's PDQ® database Study ID Numbers: CDR0000355130; UCLA-0308111; ABBOTT-M02-448 Record last reviewed: February 2004 Record first received: April 7, 2004 ClinicalTrials.gov Identifier: NCT00080730 ClinicalTrials.gov processed this record on 2004-09-09 -------------------------------------------------------------------------------- ZD6474 and Docetaxel in Treating Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer This study is currently recruiting patients. Sponsored by Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) Purpose RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. ZD6474 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: Randomizedphase II trial to compare the effectiveness of different regimens of ZD6474 combined with docetaxel in treating patients who have locally advanced or metastaticnon-small cell lung cancer that is refractory to platinum-based chemotherapy. Condition Treatment or Intervention Phase Non-small cell lung cancer Drug: ZD6474 Drug: docetaxel Procedure: anti-cytokine therapy Procedure: antiangiogenesis therapy Procedure: biological response modifier therapy Procedure: chemotherapy Procedure: enzyme inhibitor therapy Procedure: growth factor antagonist therapy Procedure: protein tyrosine kinase inhibitor therapy Phase II MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Lung Cancer; Respiratory Diseases Study Type: Interventional Study Design: Treatment Official Title: Phase II Randomized Study of ZD6474 and Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Refractory to Platinum-Based Chemotherapy Further Study Details: OBJECTIVES: Compare the efficacy of ZD6474 and docetaxel vs docetaxel and placebo, in terms of progression-free survival, in patients with locally advanced or metastatic non-small cell lung cancer refractory to platinum-based chemotherapy. Compare the tolerability and safety of these regimens, in terms of incidence and nature of adverse effects and electrocardiogram changes, in these patients. Compare the objective response rate and duration of response of patients treated with these regimens. Compare the pharmacokinetics of these regimens in these patients. Compare the overall survival of patients treated with these regimens. Compare objective tumor response and progression-free survival with the biological assessment of these regimens in these patients. Compare quality of life, lung cancer symptoms, and performance status of patients treated with these regimens. OUTLINE: This is a multicenter, two-phase study comprising an open-label phase followed by a double-blind, randomized phase. Open-label phase: Patients receive docetaxel IV over 1 hour on day 1 and oral ZD6474 once daily beginning on day 2. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are randomized to 1 of 3 treatment arms. Arm I: Patients receive docetaxel IV over 1 hour on day 1 and oral ZD6474 once daily beginning on day 1. Arm II: Patients receive docetaxel as in arm I and ZD6474 as in arm I but at a higher dose. Patients receive docetaxel as in arm I and oral placebo once daily beginning on day 1. In all arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, after the first 4 courses, and then after every other course thereafter. Patients are followed at 30 days and then every 6 weeks thereafter. PROJECTED ACCRUAL: A total of 129 patients (9 patients for the open-label phase, 120 patients [40 per treatment arm] for the randomized phase) will be accrued for this study within approximately 8 months (3 months for the open-label phase, 5 months for the randomized phase). Eligibility Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both Criteria DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer Locally advanced or metastatic disease (stage IB-IV) No mixed small cell histology No bronchoalveolar carcinoma Failed first-line platinum-based chemotherapy At least one unidimensionally measurable lesion At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan No brain metastases or spinal cord compression unless treated at least 4 weeks before study and stable without steroids for at least 1 week PATIENT CHARACTERISTICS: Age 18 and over Performance status WHO 0-1 Life expectancy At least 12 weeks Hematopoietic Neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than upper limit of normal (ULN) AST and ALT no greater than 1.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN No hepatitis B Renal Creatinine no greater than 1.5 times ULN Calcium (adjusted for albumin) normal Cardiovascular No significant cardiovascular disease No symptomatic heart failure or angina within the past 3 months No cardiac disease that increases risk of a ventricular arrhythmia No clinically significant arrhythmia (e.g., multifocal premature ventricular contractions, bigeminy, trigeminy, or ventricular tachycardia) that is symptomatic or requires treatment No symptomatic sustained ventricular tachycardia No chronic atrial fibrillation No history of QT prolongation with other medications No congenital long QT syndrome No QTc with Bazett's correction unmeasurable or more than 460 msec by screening electrocardiogram LVEF at least 45% by MUGA (for patients with prior anthracycline therapy with total dose greater than 450 mg/m^2) Pulmonary Oxygen saturation at least 90% on room air No requirement for supplemental oxygen Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective double-barrier contraception No known hypersensitivity to drugs formulated with polysorbate 80 HIV negative No severe or uncontrolled systemic disease Magnesium normal Potassium at least 4.0 meq/L PRIOR CONCURRENT THERAPY: Biologic therapy More than 6 weeks since prior suramin No concurrent biological response modifiers (including cytokines) Chemotherapy See Disease Characteristics Prior docetaxel or paclitaxel allowed More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy See Disease Characteristics No concurrent hormonal therapy for cancer Radiotherapy No prior chest radiotherapy More than 4 weeks since other prior radiotherapy No concurrent radiotherapy Surgery Not specified Other No prior agents that block the endothelial growth factor (EGF) or vascular EGF pathways More than 4 weeks since prior systemic anticancer therapy More than 4 weeks since prior investigational agents More than 2 weeks since prior, and no concurrent, treatment with any of the following: Amiodarone Chlorpromazine Ketoconazole Itraconazole Troleandomycin Erythromycin Diltiazem Verapamil Phenytoin Carbamazepine Rifampin More than 4 weeks since prior barbiturates More than 2 weeks since prior therapeutic-dose warfarin No concurrent therapeutic-dose warfarin No concurrent barbiturates No concurrent medications known to affect QTc No concurrent medications known to prolong QT interval or induce Torsade de Pointes No other concurrent anticancer therapy No other concurrent cytotoxic therapy for cancer No other concurrent investigational agents Low dose-warfarin for catheter clot prophylaxis allowed Location and Contact Information California Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, 90095, United States; Recruiting Diane Prager, MD 310-794-7758 Study chairs or principal investigators Diane Prager, MD, Principal Investigator, Jonsson Comprehensive Cancer Center More Information Clinical trial summary from the National Cancer Institute's PDQ® database Study ID Numbers: CDR0000269881; UCLA-0208009; ZENECA-6474IL/0006 Record last reviewed: January 2003 Record first received: February 5, 2003 ClinicalTrials.gov Identifier: NCT00054093 ClinicalTrials.gov processed this record on 2004-09-09 -------------------------------------------------------------------------------- Monoclonal Antibody ABX-EGF in Treating Patients With Renal (Kidney), Prostate, Pancreatic, Non-Small Cell Lung, Colon or Rectal, Esophageal, or Gastroesophageal Junction Cancer This study is currently recruiting patients. Sponsored by Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) Purpose RATIONALE: Monoclonal antibodies such as ABX-EGF can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody ABX-EGF in treating patients who have either renal (kidney), prostate, pancreatic, non-small cell lung, colon, rectal, esophageal, or gastroesophageal junction cancer. Condition Treatment or Intervention Phase Colorectal Cancer Esophageal Cancer kidney tumor Lung Cancer Pancreatic Cancer Prostate Cancer Drug: monoclonal antibody ABX-EGF Procedure: antibody therapy Procedure: biological response modifier therapy Procedure: monoclonal antibody therapy Phase I MedlinePlus related topics: Colorectal Cancer; Esophageal Cancer; Kidney Cancer; Lung Cancer; Pancreatic Cancer; Prostate Cancer Study Type: Interventional Study Design: Treatment Official Title: Phase I Study of Monoclonal Antibody ABX-EGF in Patients With Renal, Prostate, Pancreatic, Non-Small Cell Lung, Colorectal, Esophageal, or Gastroesophageal Junction Cancer Further Study Details: OBJECTIVES: Determine the safety of monoclonal antibody ABX-EGF in patients with renal, prostate, pancreatic, non-small cell lung, colorectal, esophageal, or gastroesophageal junction cancer. Determine the pharmacokinetics and the dose-response relationship of this drug in this patient population. Evaluate the clinical effect of this drug in this patient population. OUTLINE: This is an open-label, dose-escalation, multicenter study. Patients receive monoclonal antibody ABX-EGF IV over 1 hour once weekly on weeks 0-3* (enrollment for the weekly dosing schedule completed as of 4/21/03 [with the exception of patients undergoing full pharmacokinetic analyses, described below]) OR once every 2 weeks on weeks 0, 2, 4, and 6* OR once every 3 weeks on weeks 0, 3, 6, and 9*. Patients undergoing full pharmacokinetic analyses receive a loading dose on week 0 and the subsequent 3 doses on weeks 3-5. NOTE: *All patients receive a total of 4 doses. Cohorts of 2-8 patients receive escalating doses of monoclonal antibody ABX-EGF until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 or 3 patients experience dose-limiting toxicity. Patients are followed every 2 weeks for 5 weeks. PROJECTED ACCRUAL: A total of 76 patients will be accrued for this study within approximately 14 months. Eligibility Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both Criteria DISEASE CHARACTERISTICS: Histologically confirmed diagnosis of 1 of the following: Renal cell cancer (RCC) Prior nephrectomy required Prostate cancer Failed prior primary therapy (e.g., surgery, radiotherapy, or chemotherapy) Failed prior hormonal therapy (e.g., antiandrogen, luteinizing hormone-releasing hormone inhibitor, or orchiectomy) Pancreatic cancer Failed at least 1 prior standard therapy regimen for unresectable metastatic disease Non-small cell lung cancer Failed at least 1 prior standard therapy regimen for unresectable metastatic disease Colorectal cancer Received 1 or more prior chemotherapy regimen(s) for advanced metastatic disease Esophageal cancer Failed prior primary therapy (e.g., surgery, radiotherapy, or chemotherapy) Gastroesophageal junction cancer Evaluable disease Epidermal growth factor receptor overexpression Tumor tissue must yield the sum of 1+, 2+, or 3+ staining in at least 10% of evaluated tumor cells No uncontrolled brain metastases No evidence of disease progression or regression after a 30-day washout period PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% OR ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1,000/mm^3 Platelet count greater than 100,000/mm^3 Hepatic: AST/ALT no greater than 2 times upper limit of normal (ULN) (3 times ULN for liver metastases) Alkaline phosphatase no greater than 2 times ULN (3 times ULN for liver metastases) Renal: Creatinine less than 2.2 mg/dL NCI renal toxicity no greater than grade 2 No hypercalcemia (antihypercalcemic therapy allowed) Cardiovascular: Ejection fraction at least 45% by MUGA No abnormal ECG or MUGA No myocardial infarction within the past year Pulmonary: No abnormal chest x-ray FEV_1 greater than 50% of predicted Other: No known allergy to ingredients of study drug No known allergy to Staphylococcus aureus Protein A HIV negative No chronic medical or psychiatric condition that would preclude study compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 2 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: At least 30 days since prior biologic therapy (e.g., antibodies, cytokines, or co-stimulatory pathway inhibitors) No other concurrent biologic therapy Chemotherapy: See Disease Characteristics At least 6 weeks since prior chemotherapy and recovered No prior chemotherapy for RCC No prior anthracyclines No concurrent chemotherapy Endocrine therapy: See Disease Characteristics Concurrent steroids allowed Concurrent hormonal therapy allowed Radiotherapy: See Disease Characteristics No prior mediastinal radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics Recovered from any recent prior surgery Other: At least 30 days since prior investigational drug or device At least 30 days since prior systemic therapy No other concurrent investigational drugs No other concurrent systemic agents or cancer therapy Location and Contact Information California Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, 90095-1738, United States; Recruiting Arie Belldegrun, MD, FACS 310-794-6584 abelldeg@surgery.medsch.ucla.edu Pennsylvania Fox Chase Cancer Center, Philadelphia, Pennsylvania, 19111, United States; Recruiting Louis M. Weiner, MD 215-728-2480 lm_weiner@fccc.edu Study chairs or principal investigators Arie Belldegrun, MD, FACS, Principal Investigator, Jonsson Comprehensive Cancer Center More Information Clinical trial summary from the National Cancer Institute's PDQ® database Study ID Numbers: CDR0000067539; UCLA-9906078; ABX-EG-9901; UCLA-9906078-04B; NCI-G00-1673 Record last reviewed: February 2004 Record first received: March 7, 2000 ClinicalTrials.gov Identifier: NCT00004879 ClinicalTrials.gov processed this record on 2004-09-09 Quote Link to comment Share on other sites More sharing options...
Angie Daughter of Bill Posted September 9, 2004 Share Posted September 9, 2004 Paddy, I'm so sorry that you guys are in a rough patch right now. There is an assistance program for Iressa. Contact the manufacturer through their website. Sorry I don't have the site address, but if you search for Iressa, you will find it easily. (I did) One of the first things that Dad's doctor asked was if he needed assistance getting the Iressa. Paddy, there is a way to get the Iressa. Don't give up. Take a deep breath and starting digging in. You WILL find a way to get it. I just know it. In my thoughts and prayers~~~ Angie Quote Link to comment Share on other sites More sharing options...
betplace Posted September 10, 2004 Share Posted September 10, 2004 Paddy, All these grat people have gotten lots of info for you. I have no info, but I am sending hugs and prayers that all is resolved in your favor and that your husband will respond well to the Iressa. Blessings Betty Quote Link to comment Share on other sites More sharing options...
Frank Lamb Posted September 10, 2004 Share Posted September 10, 2004 Paddy,Please do what everyone is telling you.Take the time & fight with everyone you have to.There must be a way to get the Iressa.Hang in there . Quote Link to comment Share on other sites More sharing options...
annjael Posted September 10, 2004 Share Posted September 10, 2004 Hi Paddy,,,,,, Have no info, only my prayers that you will find some way to get the Iressa David needs. Hugs to you both,,,,like the others have said, leave no stone unturned, fighting for what you need. You have all of us behind you too!!! Peace, Annjael Quote Link to comment Share on other sites More sharing options...
Kel M Posted September 10, 2004 Share Posted September 10, 2004 Paddy, My thoughts and prayers are with you and your family as you tough through this. Keep fighting the good fight! Kel Quote Link to comment Share on other sites More sharing options...
paddy Posted September 10, 2004 Author Share Posted September 10, 2004 Thank you all so very much. Your info is all very usefull and we intend to "work the phones" as soon as possible. Thank you too for all your good wishes and prayers they really lift my heart. I consider you all my/our very good friends.Paddy PS. Thank You Katy B, I am working on it! Paddy Quote Link to comment Share on other sites More sharing options...
paddy Posted September 10, 2004 Author Share Posted September 10, 2004 Just to let you know that we have applied for forms to get into a "demonstration" of Iressa, as per Elain's suggestion. When we first asked , the "technician?" said they didn't cover any cancer medications taken by mouth . We told them that we had it from Yahoo News that they did!"The fellow then apologized and said he had forgotten about that! He then agreed to send us the forms. We have to receive the files, fill them in, get our Oncologists approval and then get them back to the medicare by September 30th. I believe it is a sort of lottery, and I am not sure how long you wait once you are accepted. In the meantime I am trying to get the onc's office to get an appointment to start Gemsar. I phoned early this morning and I still haven't had a reply! I shall be phoning again soon! Thanks All , Paddy. Quote Link to comment Share on other sites More sharing options...
Elaine Posted September 10, 2004 Share Posted September 10, 2004 Paddy, I was only too happy to help in some way. I am still at a loss for words at the "technician's" memory loss or whatever you might call it!! A lottery sounds so heartless, soesn't it? I hope things work out and I am glad you have a plan in place. My best to you both. love and fortitude elaine Quote Link to comment Share on other sites More sharing options...
Laurie Posted September 11, 2004 Share Posted September 11, 2004 Paddy, I'm so sorry to hear what you are going through. My heart and prayers are with you and your husband. I had heard the same thing about the manufactures offering assistance directly through their websites too. Sending Hugs Laurie Quote Link to comment Share on other sites More sharing options...
Nushka Posted September 11, 2004 Share Posted September 11, 2004 Paddy, I am so sorry to hear about your problems with Iressa...I hope they get worked out soon. Everyone has been so helpful...surely you will find something that will work. Keep your chin up and give it the ole college try. Keeping you in my prayers. Nina Quote Link to comment Share on other sites More sharing options...
Melinda Posted September 11, 2004 Share Posted September 11, 2004 Paddy-- I wish I had useful information for you... Thank goodness for all the others on this site (and what fighters that all are!). Please know that our thoughst and prayers are with you after such a difficult--and disheartening!--appointment. Please let us know if we can help in any way. Melinda and Geoff Quote Link to comment Share on other sites More sharing options...
ginnyde Posted September 11, 2004 Share Posted September 11, 2004 Paddy, I have been away so I am sorry I am late posting. I find it incomprehensible that any human being would be denied life saving medication. I would try every place - Alcase, the American Cancer Society, the drug company, your doctor, your hospital, your church. Since the news seems to be very encouraging with Iressa, the drug company should be recouping their research expense quickly I would think, so that may be your best chance. Don't give up hope Paddy, I know David will get the meds he needs. Quote Link to comment Share on other sites More sharing options...
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