At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically documented adenocarcinoma of colon or rectum with locally advanced (unresectable) or metastatic disease
- ✓Wildtype K-ras gene (patients with K-ras mutation are ineligible)
- ✓No prior systemic treatment for advanced or metastatic colorectal cancer
- ✓Prior adjuvant chemotherapy allowed if completed >12 months before recurrence
- ✕Prior or concurrent malignancy except basal/squamous cell skin cancer, in situ cervical cancer, or cancer disease-free for ≥5 years
- ✕For FOLFIRI recipients: evidence of Gilbert's Syndrome or homozygosity for UGT1A1*28 allele
- ✕For FOLFOX recipients: sensory peripheral neuropathy ≥grade 2 at baseline
- ✕CNS metastases or carcinomatous meningitis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Trial of Irinotecan / 5-FU / Leucovorin or Oxaliplatin / 5-FU/ Leucovorin With Bevacizumab, or Cetuximab (C225), or With the Combination of Bevacizumab and Cetuximab for Patients With Untreated Metastatic Adenocarcinoma of the Colon or Rectum
In Brief
A Phase 3 clinical trial evaluating bevacizumab, cetuximab, and 2 other interventions for Colorectal Cancer. Completed, enrolled 2,334 participants across 683 sites in 2 countries.
Detailed Summary
PURPOSE: This randomized phase III trial is studying cetuximab and/or bevacizumab when given together with combination chemotherapy to compare how well they work in treating patients with metastatic colorectal cancer. RATIONALE: Monoclonal antibodies, such as cetuximab and bevacizumab, 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. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as fluorouracil, leucovorin, oxaliplatin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibodies together with combination chemotherapy may kill more tumor cells. It is not yet known whether combination chemotherapy is more effective with cetuximab and/or bevacizumab in treating patients with colorectal cancer.
Study Details
Timeline
Interventions
Given IV
Given IV
Patients receive oxaliplatin 85 mg/m\^2 IV infused over two hours followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus, then 2400 mg/m\^2 continuous IV infusion over 46-48 hours
Patients receive irinotecan 180 mg/m\^2 IV infused over 90 minutes followed by leucovorin 400 mg/m\^2 IV over 2 hours followed by 5-FU 400 mg/m\^2 IV bolus following leucovorin then 2400 mg/m\^2 continuous IV infusion over 46-48 hours.