Capecitabine and Oxaliplatin With or Without Cetuximab in Treating Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery
- Conditions
- Colorectal Cancer
- Interventions
- Registration Number
- NCT00227734
- Lead Sponsor
- Swiss Group for Clinical Cancer Research
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Secondary
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 74
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm I capecitabine and oxaliplatin Patients receive oral capecitabine twice daily on days 1-15 and oxaliplatin IV over 2 hours on day 1. Arm II capecitabine and oxaliplatin + cetuximab Patients receive capecitabine and oxaliplatin as in arm I and cetuximab IV over 1-2 hours on days 1 and 8
- Primary Outcome Measures
Name Time Method Objective response (complete response [CR] and partial response [PR]) measured after completion of study treatment
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (18)
Inselspital Bern
🇨ðŸ‡Bern, Switzerland
Kantonsspital - St. Gallen
🇨ðŸ‡St. Gallen, Switzerland
Saint Claraspital AG
🇨ðŸ‡Basel, Switzerland
Kantonsspital Bruderholz
🇨ðŸ‡Bruderholz, Switzerland
Kantonsspital Baden
🇨ðŸ‡Baden, Switzerland
Spitaeler Chur AG
🇨ðŸ‡Chur, Switzerland
Ospedale Civico
🇨ðŸ‡Lugano, Switzerland
Hirslanden Klinik Aarau
🇨ðŸ‡Aarau, Switzerland
Praxis Dr. Streit
🇨ðŸ‡Baden, Switzerland
Hopital Cantonal Universitaire de Geneve
🇨ðŸ‡Geneva, Switzerland
Kantonsspital
🇨ðŸ‡Liestal, Switzerland
Stadtspital Waid
🇨ðŸ‡Zurich, Switzerland
UniversitaetsSpital Zuerich
🇨ðŸ‡Zurich, Switzerland
Kantonspital Aarau
🇨ðŸ‡Aarau, Switzerland
Universitaetsspital-Basel
🇨ðŸ‡Basel, Switzerland
Praxis Dr. Beretta
🇨ðŸ‡Rheinfelden, Switzerland
Regionalspital
🇨ðŸ‡Thun, Switzerland
City Hospital Triemli
🇨ðŸ‡Zurich, Switzerland