Capecitabine and Oxaliplatin With or Without Cetuximab in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, 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. It is not yet known whether giving capecitabine and oxaliplatin together with cetuximab is more effective than capecitabine and oxaliplatin in treating colorectal cancer.
PURPOSE: This randomized phase II trial is studying how well giving capecitabine and oxaliplatin together with cetuximab works compared to capecitabine and oxaliplatin in treating patients with metastatic colorectal cancer that cannot be removed by surgery.
|Colorectal Cancer||Drug: capecitabine and oxaliplatin + cetuximab Drug: capecitabine and oxaliplatin||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Capecitabine and Oxaliplatin Alone or in Combination With Cetuximab as First-Line Treatment for Metastatic EGFR-Positive Colorectal Cancer, A Randomized Multicenter Phase II Trial|
- Objective response (complete response [CR] and partial response [PR]) measured after completion of study treatment
- Clinical benefit (CR, PR, and stable disease [SD]) measured at 18 weeks after randomization
- Time to progression
- Overall survival
- Time to treatment failure measured after completion of study treatment
- Adverse drug reactions measured after completion of study treatment
|Study Start Date:||June 2004|
|Study Completion Date:||February 2006|
|Primary Completion Date:||October 2005 (Final data collection date for primary outcome measure)|
Active Comparator: Arm I
Patients receive oral capecitabine twice daily on days 1-15 and oxaliplatin IV over 2 hours on day 1.
Drug: capecitabine and oxaliplatin
capecitabine and oxaliplatin without cetuximab
Active Comparator: Arm II
Patients receive capecitabine and oxaliplatin as in arm I and cetuximab IV over 1-2 hours on days 1 and 8
Drug: capecitabine and oxaliplatin + cetuximab
- Compare the efficacy of capecitabine and oxaliplatin with vs without cetuximab in patients with epidermal growth factor receptor-positive metastatic unresectable colorectal cancer.
- Compare the objective response (complete and partial response) in patients treated with these regimens.
- Compare the safety of these regimens in these patients.
- Compare the clinical benefit (complete response, partial response, or stable disease for at least 18 weeks) in patients treated with these regimens.
- Compare overall survival, time to progression, and time to treatment failure in patients treated with these regimens.
OUTLINE: This is a multicenter, randomized study. Patients are stratified according to performance status (0 vs 1), type of metastases (synchronous vs metachronous), prior adjuvant chemotherapy (yes vs no), and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral capecitabine twice daily on days 1-15 and oxaliplatin IV over 2 hours on day 1.
- Arm II: Patients receive capecitabine and oxaliplatin as in arm I and cetuximab IV over 1-2 hours on days 1 and 8.
In both arms, courses repeat every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients will be followed every 3 months for 1 year and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 74 patients (37 per treatment arm) will be accrued for this study within 1.5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00227734
|Aarau, Switzerland, 5001|
|Hirslanden Klinik Aarau|
|Aarau, Switzerland, CH-5001|
|Praxis Dr. Streit|
|Baden, Switzerland, 5404|
|Baden, Switzerland, CH-5404|
|Saint Claraspital AG|
|Basel, Switzerland, CH-4016|
|Basel, Switzerland, CH-4031|
|Bern, Switzerland, CH-3010|
|Bruderholz, Switzerland, CH-4101|
|Spitaeler Chur AG|
|Chur, Switzerland, CH-7000|
|Hopital Cantonal Universitaire de Geneve|
|Geneva, Switzerland, CH-1211|
|Liestal, Switzerland, CH-4410|
|Lugano, Switzerland, CH-6900|
|Praxis Dr. Beretta|
|Rheinfelden, Switzerland, 4310|
|Kantonsspital - St. Gallen|
|St. Gallen, Switzerland, CH-9007|
|Thun, Switzerland, 3600|
|City Hospital Triemli|
|Zurich, Switzerland, 8063|
|Zurich, Switzerland, CH-8037|
|Zurich, Switzerland, CH-8091|
|Study Chair:||Markus M. Borner, MD||University Hospital Inselspital, Berne|
|Principal Investigator:||Dieter Koeberle, MD||Cantonal Hospital of St. Gallen|