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Cetuximab clinical trial programme accelerates

Category: Cancer/Oncology News

Article Date: 06 Nov 2005

The clinical trial programme for cetuximab (Erbitux) is gathering pace with new studies underway in a broad range of malignancies, according to presentations at the 13th Annual European Conference on Clinical Oncology, held this week in Paris, France.

Scientists from the Fédération Francophone de Cancérologie Digestive (FFCD) announced a major pan-European collaboration to investigate whether cetuximab in combination with oxaliplatin-based chemotherapy (FOLFOX-4) will reduce disease recurrence and prolong survival in fully resected stage III colon cancer after surgery.

The intergroup study will be conducted in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC) and will recruit 2,000 patients.

Around 25 percent of the 370,000 patients in Europe diagnosed with colorectal cancer each year present with stage III disease, in which the tumor has already spread through the bowel wall and to regional lymph nodes. Although surgery followed by chemotherapy has significantly improved survival, approximately one third of the patients are likely to experience disease recurrence within three years.

In the PETACC-8 study, patients with fully resected stage III colorectal cancer will be randomly assigned to receive either cetuximab in combination with FOLFOX-4 or FOLFOX-4 alone, after surgery. Treatments will be administered for 6 months.

About 340 leading centres will be open for recruitment across Europe, including France, Germany, Belgium, Spain, UK, Austria, Italy, Denmark, Portugal, Sweden, and others. “With more and more people developing colorectal cancer, and a recurrence rate of at least 30 percent in patients with fully resected stage III disease, we need to improve patients' outcomes by including new targeted therapies in our therapeutic armamentarium,” said Dr Julien Taïeb from the Groupe Hospitalier Pitié Salpêtrière, Paris, and the study principal investigator. “We really hope that the combination of cetuximab and FOLFOX, already seen to be efficient in patients with advanced disease, will significantly improve disease-free survival after surgery.”

First line in colorectal

Also at the ECCO 13, Merck KGaA announced that recruitment has just been completed for CRYSTAL, a global phase III clinical trial examining first-line use of cetuximab in the treatment of metastatic colorectal cancer. In the study, 1,212 patients who have received no prior chemotherapy apart from in the adjuvant (post-surgery) setting were randomized to receive either Cetuximab in combination with 5-fluorouracil (5-FU) and folinic acid (FA) plus irinotecan or 5-FU/FA plus irinotecan alone. The patients were recruited at 189 centers worldwide, including Europe, Australia, South Africa, Latin America and Asia. Recruitment. which began in August 2004 was completed earlier than expected. The primary endpoint of the study is progression-free survival. Secondary endpoints are overall survival, response rate, quality of life and safety. Results are expected to be available early next year.

“With five-year survival reported at only 3 percent in patients with metastatic colorectal cancer, there is a real need to concentrate efforts on clinical development programs that may improve treatment options and long-term outcomes for these patients,” said Professor Eric Van Cutsem of the University Hospital Gasthuisberg in Leuven, Belgium, and CRYSTAL lead investigator. “Preliminary studies of Erbitux in the first-line setting are showing consistently high response rates and some very promising outcomes. It is now important to establish how introducing Erbitux earlier in the treatment strategy may benefit patients in the long-term.”

Also announced at ECCO, were results from an independent expert review of the ACROBAT study (phase II study of cetuximab in combination with FOLFOX-4 in the first-line treatment of 42 patients with metastatic colorectal cancer. The independent expert review confirmed a response rate of 79 percent (investigator assessment was 81 percent).

The review confirmed that 10 patients (23 percent) whose cancer had spread beyond the bowel became eligible to receive surgical resection for previously inoperable liver metastases. Surgical resection provides the best hope for five-year survival. For patients who have not had surgery and who are treated with the best available chemotherapy without cetuximab, median survival is approximately 20 months.

First-line treatment of metastatic colorectal cancer is also being investigated in the COIN study - a phase III trial conducted by the Clinical Trials Unit of the UK's Medical Research Council, United Kingdom. The trial involves 2,400 patients and comprises three arms: continuous oxaliplatin-based chemotherapy (control), continuous oxaliplatin-based chemotherapy with cetuximab and intermittent oxaliplatin-based chemotherapy.

Merck KGaA's phase III clinical trial program involves approximately 5,000 patients and is investigating the use of cetuximab in first-line treatment of metastatic colorectal cancer in combination with best available chemotherapies _ irinotecan- and oxaliplatin-based _ in the first- and second-line setting as well as first-line settings in non-small-cell lung cancer and squamous cell carcinoma of the head and neck.

Cetuximab specifically targets the epidermal growth factor receptor (EGFR) which is often present on cancer cells. Blocking the EGFR helps prevent tumors from growing and cancer cells from spreading to other organs in the body. Cetuximab is currently under study in a range of EGFR-expressing tumor types including colon cancer, squamous cell carcinoma of the head and neck, non-small-cell lung cancer, pancreatic cancer and rectal cancer. A marketing authorization application was submitted by Merck KGaA on 30 August 2005 to Swissmedic and the European Medicines Agency (EMEA) for approval to extend the use of cetuximab in the treatment of head and neck cancer.

“In head and neck cancer, new therapies are needed to inhibit the cancer process and to increase the activity of more common therapies, including chemotherapy and radiotherapy without increasing toxicities such as mucositis,” said Professor Jean Louis Lefebvre, Head of the Department of Head and Neck Surgery, Centre Oscar Lambret, Lille, France.

Reviewing current trials of cetuximab in the treatment of head and neck cancer, Professor Jan Vermorken, University Hospital, Antwerp, Belgium said that cetuximab may prolong survival of head and neck cancer patients who have failed platinum therapy (showing a 2.5 months increase compared with data from a retrospective study using conventional therapies).

“Erbitux does not increase toxicities associated with platinum-based chemotherapy, and skin reactions, the most frequently occurring side-effect can be well managed.”

In locoregionally advanced head and neck cancer treated by radiotherapy, he said that cetuximab showed activity and significantly improved locoregional control. “Erbitux significantly improves survival in these patients by 13% _ an additional 26 months median survival.”




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