Cetuximab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver and/or Lung

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: 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. Drugs used in chemotherapy, such as irinotecan, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with combination chemotherapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab together with combination chemotherapy works as first-line therapy in treating patients with colorectal cancer that has spread to the liver and/or lung.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute, France
• Collaborator: University Hospital, Grenoble
• Treatments: Calcium; Cetuximab; Fluorouracil; Irinotecan; Leucovorin; Levoleucovorin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the colon or rectum

• Must have synchronous or metasynchronous unresectable hepatic metastases

• Less than 8 hepatic metastases

• Less than 6 segments of liver involvement with metastases

• No more than 2 potentially resectable extrahepatic (e.g., pulmonary) metastases

• Patients with visceral metastases that are potentially resectable after chemotherapy (i.e., tumor regression) are eligible

• At least 1 measurable metastasis by CT scan or MRI

• No brain metastases, bone metastases, or carcinomatous meningitis

• No celiac lymph node involvement or peritoneal cancer

PATIENT CHARACTERISTICS:

• WHO performance status 0-1

• Life expectancy > 3 months

• ANC ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• PT rate > 70%

• Bilirubin < 30 μmol/L

• Creatinine < 130 μmol/L

• Creatinine clearance > 60 mL/min

• Not pregnant or nursing

• No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix

• No severe unstable angina

• No symptomatic heart failure

• No other concurrent illness

PRIOR CONCURRENT THERAPY:

• At least 3 months since prior adjuvant anticancer chemotherapy

• No concurrent participation in another clinical trial