Cetuximab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver and/or Lung (ERBIFORT)
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as irinotecan, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab together with combination chemotherapy works as first-line therapy in treating patients with colorectal cancer that has spread to the liver and/or lung.
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Frontline Chemotherapy "Reinforced" for Cancers of the Colon and Rectum With Potentially Resectable Hepatic and/or Pulmonary Metastases: Association of FOLFIRI and ERBITUX|
- Tumor response rate [ Time Frame: From baseline to end of treatment ] [ Designated as safety issue: No ]
- Rate of resectability [ Time Frame: From baseline to end of treatment ] [ Designated as safety issue: No ]
- Overall and disease-free survival [ Time Frame: From baseline to end of treatment ] [ Designated as safety issue: No ]
- Tolerability [ Time Frame: From baseline to end of treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2007|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
|cetuximab, FOLFIRI||Biological: cetuximab Biological: filgrastim Drug: fluorouracil Drug: irinotecan hydrochloride Drug: leucovorin calcium|
- Determine the tumor response rate in patients with colorectal cancer and hepatic and/or pulmonary metastases treated with cetuximab and FOLFIRI chemotherapy comprising irinotecan hydrochloride, leucovorin calcium, and fluorouracil as first-line therapy.
- Determine the rate of resectability in patients treated with this regimen.
- Determine the overall and disease-free survival of patients treated with this regimen.
- Determine the tolerability of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV over 60-120 minutes on days 1 and 8. Patients also receive FOLFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 48 hours on days 1 and 2. Patients with 7/6 or 7/7 genotypes also receive filgrastim (G-CSF) as primary prophylaxis (patients with 6/6 genotypes receive G-CSF as secondary prophylaxis). Treatment repeats every 2 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity. Within 6 weeks after the completion of cetuximab and FOLFIRI chemotherapy, patients with responding disease undergo surgical resection of visceral metastases.
|CHU de Grenoble - Hopital Michallon|
|Grenoble, France, 38043|
|Study Chair:||Jean Marc Phelip, MD, PhD||University Hospital, Grenoble|