Cetuximab and Capecitabine in Treating Patients With Metastatic Colorectal Cancer That Failed Irinotecan Treatment

• Status: Terminated
• Trial end date: 1969-12-31
• 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. Cetuximab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as capecitabine, 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 capecitabine may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab together with capecitabine work in treating patients with metastatic colorectal cancer.

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

Details

• Lead Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Capecitabine; Cetuximab

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of metastatic colorectal cancer

• Measurable disease

• Disease progression during prior fluoropyrimidine-containing therapy comprising irinotecan with or without oxaliplatin

• Received standard first- and second-line irinotecan and oxaliplatin-based therapy

• Patients who completed 1 prior treatment for metastatic disease but refused standard second-line therapy are eligible

• Patients who's disease progressed within 6 months of previous therapy are eligible

• EGFR negative patients allowed

• No untreated or uncontrolled brain metastasis

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Absolute neutrophil count ≥ 1,500/μL

• Platelet count ≥ 100,000/μL

• ALT ≤ 5 times upper limit of normal (ULN)

• Alkaline phosphatase ≤ 5 times ULN

• Serum creatinine ≤ 1.5 mg/dL

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other prior malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

• No serious intercurrent infections or medical problems

• No active or uncontrolled infections

• No significant history of uncontrolled cardiac disease, including any of the following:

• Uncontrolled hypertension

• Unstable angina

• Myocardial infarction within the past 6 months

• Uncontrolled congestive heart failure

• Cardiomyopathy with decreased ejection fraction

• No prior severe infusion reaction to a monoclonal antibody

• No known dihydropyrimidine dehydrogenase deficiency or evidence of past hypersensitivity to fluoropyrimidine

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No more than 2 prior treatments for metastatic colorectal cancer

• More than 2 weeks since prior therapy

• Prior radiotherapy allowed if < 30% of bone marrow involvement

• No other concurrent investigational agents

• No concurrent highly active antiretroviral therapy for HIV-positive patients

• No prior therapy that specifically and directly targets the EGFR pathway