Combination Chemotherapy With or Without Cetuximab in Treating Patients With Stage III Colon Cancer That Was Completely Removed By Surgery
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, or fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. 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. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy with or without cetuximab after surgery may kill any remaining tumor cells and keep colon cancer from coming back. It is not yet known whether giving combination chemotherapy together with cetuximab is more effective than giving combination chemotherapy alone in treating colon cancer.
PURPOSE: This randomized phase III trial is studying combination chemotherapy and cetuximab to see how well they work compared to combination chemotherapy alone in treating patients with stage III colon cancer that was completely removed by surgery.
Drug: leucovorin calcium
Procedure: adjuvant therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Adjuvant Treatment of Fully Resected Stage III Colon Cancer With FOLFOX-4 Versus FOLFOX-4 Plus Cetuximab|
- Disease-free survival [ Time Frame: May 2012 ] [ Designated as safety issue: No ]
- 3-year disease-free survival [ Time Frame: May 2012 ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: May 2012 ] [ Designated as safety issue: No ]
- 5-year overall survival [ Time Frame: May 2012 ] [ Designated as safety issue: No ]
- Treatment compliance [ Time Frame: May 2012 ] [ Designated as safety issue: No ]
- Identification of prognostic factors [ Time Frame: May 2012 ] [ Designated as safety issue: No ]
- Safety [ Time Frame: May 2012 ] [ Designated as safety issue: Yes ]
- Markers predictive for relapse and/or treatment efficacy [ Time Frame: May 2012 ] [ Designated as safety issue: No ]
|Study Start Date:||November 2005|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
- Compare the disease-free survival rates in patients with completely resected stage III colon cancer treated with adjuvant oxaliplatin, leucovorin calcium, and fluorouracil with vs without cetuximab.
- Compare the 3-year disease-free survival rate and 5-year overall survival rate in patients treated with these regimens.
- Compare the overall survival of patients treated with these regimens.
- Compare the treatment compliance of patients treated with these regimens.
- Determine the prognostic factors and markers predictive for relapse and/or treatment efficacy in patients treated with these regimens.
- Compare the safety of these regimens in these patients.
OUTLINE: This is an open-label, randomized, controlled, multicenter study. Patients are stratified according to obstruction/perforation status (no obstruction and no perforation vs obstruction and/or perforation), N stage (N1 vs N2), and T stage (T1-3 vs T4). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 22 hours on days 1 and 2.
- Arm II: Patients receive chemotherapy as in arm I plus cetuximab IV over 1-2 hours on days 1 and 8.
In both arms, treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for approximately 5 years.
PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study.
|Avignon, France, 84902|
|CHU de Caen|
|Caen, France, 14033|
|Hopital Robert Boulin|
|Libourne, France, 33500|
|Paris, France, 75651|
|Paris, France, 75970|
|Hopital Bichat - Claude Bernard|
|Paris, France, 75018|
|Centre Hospitalier Yves Le Foll|
|Saint Brieuc Cedex 1, France, BP 2367|
|Nouvelle Clinique Generale|
|Valence, France, 26000|
|Study Chair:||Julien Taieb, MD||CHU Pitie-Salpetriere|