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Information Needed on Clinical Trials


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Hello Everybody,

My mom had her follow-up visit with her onc yesterday. She just finished 10 rounds of radiation and has definitely improved, she is getting around a lot easier and the pain has certainly decreased in her lower back. Her onc discussed with us her upcoming chemo and suggested to us a Phase 3 clinical trial. I am very new to the world of clinical trials. Why would someone choose to go into a clinical trial rather than go with standardized treatment? What is the difference between Phase 1, 2 or 3 clinical trials? Is anyone on the Genasense/Taxotere trial right now? The doctor did explain this trial is sponsored by the drug company and not the Cancer Institute. Does that make a difference?

Thanks for all your help! :D


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Hi Denise,

Glad your mother is improving. I’ve never been in a clinical trail, but here are some websites with info on it. Hope this helps. Peace, take and God Bless.


http://www.centerwatch.com/patient/studies/cat34.html (Clinical Trials: Lung Cancer)

http://www.centerwatch.com/patient/backgrnd.html (Background Information on Clinical (Trails) Research)


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With Every Breath A Lung Cancer Guidebook / From ALCASE / A Wealth Of Information / Free

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The Cancer Survival Toolbox / Free / From NCCS


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I'm new to the world of cancer and clinical trials as well. My mother in law is scheduled to start her treatment next Monday as long as everything goes ok when she sees the radiation oncologist tomorrow.

She decided to participate in a clinical trial also. She was concerned about trying out a new med instead of a proven therapy. It was a hard decision but once the doctors explained that the particular trial that they were talking about is basically a routine course of treatment with one added drug (OSI-774) she jumped at the chance. It really is scary~not knowing if or how the medication will help. This is a NCI trial in conjunction with the U of Chicago.

I did a search of the clinical trials and came up with only one that lists both meds that you mentioned. Here's a cut/paste if you'd like. If this is the same one, it says that it's being sponsored also by the NCI.

http://www.clinicaltrials.gov/ct/show/N ... 41?order=1

My daughter also has a rare genetic disease. Right now, there is no course of treatment for it except a clinical trial with a bone marrow transplant. We decided not to participate in that because the risk of the chemo prior to the BMT is too great. Because this disease causes a weak immune system, her geneticist only gives her a 50% chance of surviving the chemo. If she does make it through that, they don't know if the BMT will take. If it does, they don't know how or if it will improve her quality of life or life expectancy. A few children made great progress, in one only his hearing improved, and in a few others, no improvement was seen. There are not many people world wide diagnosed with this disease so the study is quite small.

Anyway, this is a tough decision. One that you need to weigh the potential benefits to the risks.

Good luck and best wishes to your family.

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"Generally", people on clinical trials get better care than those not on trials

Phase I usually is to test safety

Phase II usually tests the maximum tolerated dose

Phase III is the last trial before for being approved

Sometimes Phase III is double-blind with placebo. So your mom may or may not get the drug being tested. Some people do not want to be involved in this kind of trial, but it is always given with standard care in addition to the trial drug


From what I have read about BCL-2 it may be a very good target for a drug. If you do the trial I hope it works


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I don't know much about the difference between the phases of clinical trials, but I thought I'd throw my .02 worth in. My mom did 7 cycles on a clinical trial - it was a new drug, given in addition to 2 standard drugs. We had a great experience with the trial - my mom received wonderful care and frequent scans. Better than that - she had a great response!

The plus of clinical trials is to have the opportunity to try brand new drugs, which may be better than the standard regimens out there. And keep in mind that many of the top drugs out there right now are pretty new on the scene. Good luck in whatever you decide.

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