Colon Cancer Clinical Trials

CALGB 80405 (NCT00265850) For Locally Advanced or Metastatic Colon or Rectal Cancer

Summary

A Randomized Phase III Trial of Irinotecan/5-FU/Leucovorin or Oxaliplatin/5-FU/Leucovorin with bevacizumab (Avastin) or cetuximab, or with the combination of bevacizumab and cetuximab for patients with untreated metastatic (spread) adenocarcinoma of the colon or rectum.

The purpose of this trial is to determine if the addition of cetuximab to FOLFIRI or FOLFOX chemotherapy with and without bevacizumab prolongs survival compared to FOLFIRI or FOLFOX with bevacizumab in patients with untreated locally advanced or metastatic colorectal cancer who have K-ras wild type tumors.

Patients receiving their doctor’s choice of FOLFOX or FOLFIRI will be randomized to bevacizumab or cetuximab. Cetuximab is supplied at no charge.

Basic Eligibility Criteria:

• Must have wild K ras gene
• Performance status of 0-1
• Must have locally advanced (non-surgical) or metastatic cancer of the colon or rectum
• No prior systemic (through bloodstream) treatment for advanced or metastatic colorectal cancer
• No prior tyrosine kinase inhibitors or drugs that target VEGF (vascular endothelial growth factors)
• No prior bevacizumab or cetuximab
• No prior radiation therapy to >25% of bone marrow
• At least 4 weeks since major surgery
• No previous or other current cancer except basal or squamous cell skin cancer, in situ cervical cancer or other cancer if disease free for 5 yrs
• No central nervous system metastases or cancer caused meningitis
• No interstitial pneumonia or symptomatic interstitial fibrosis of lung
• No serious pleural effusion or serious ascites
• No uncontrolled seizures or active neurological disease
• No current congestive heart failure
• No history of serious bleeding (within 6 months0 unless source removed
• No GI (gastrointestinal) perforation (within 12 months)
• No arterial clotting events such as TIA (temporary mini-stroke), CVA (stroke), unstable angina or MI (heart attack) within 6 months
• No serious peripheral (blockage in arteries of the extremities) vascular disease
• No serious non healing wound, ulcer or bone fracture
• Not pregnant or nursing