Cetuximab and Bevacizumab as First-Line Therapy Followed By Combination Chemotherapy and Bevacizumab With or Without Cetuximab as Second-Line Therapy in Treating Patients With Stage IV Colorectal Cancer

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as oxaliplatin, 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 monoclonal antibodies together with combination chemotherapy may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying how well giving cetuximab together bevacizumab works as first-line therapy, followed by combination chemotherapy and bevacizumab with or without cetuximab as second-line therapy in treating patients with stage IV colorectal cancer.

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

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bevacizumab; Calcium; Cetuximab; Fluorouracil; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed stage IV colorectal cancer

• Measurable disease, defined as at least one lesion whose longest diameter can be accurately measured as ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan

• Must not be a candidate for neoadjuvant therapy

• No CNS or brain metastases

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Life expectancy ≥ 12 weeks

• ANC ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Hemoglobin ≥ 10.0 g/dL

• Total bilirubin < 1.5 times upper limit of normal (ULN)

• Alkaline phosphatase ≤ 3 times ULN

• AST ≤ 3 times ULN

• Creatinine ≤ 1.5 x times ULN

• Proteinuria < 1+ by urinalysis OR proteinuria < 1 g by 24-hour urine collection

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• English-speaking patients must have the ability to complete questionnaires by themselves or with assistance

• Must be willing to provide blood and tissue samples for research purposes

• No history of hypertensive crisis or hypertensive encephalopathy

• No blood pressure > 150/100 mm Hg

• No New York Heart Association (NYHA) class II-IV congestive heart failure

• No myocardial infarction or unstable angina within the past 6 months

• No stroke or transient ischemic attack within the past 6 months

• No clinically significant vascular disease (e.g., aortic aneurysm or aortic dissection)

• No clinically significant peripheral vascular disease

• No evidence of bleeding diathesis or coagulopathy

• No significant traumatic injury within the past 28 days

• No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months

• No serious nonhealing wound, ulcer, or bone fracture

PRIOR CONCURRENT THERAPY:

• No prior nonsurgical treatment for stage IV disease

• Adjuvant therapy allowed if completed > 6 months prior to study registration

• More than 4 weeks since prior and no concurrent or planned participation in another experimental drug study

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

• No prior monoclonal antibody therapy

• More than 28 days since prior major surgery or open biopsy

• More than 7 days since prior minor surgery, such as fine-needle aspirations or core biopsies

• Placement of a vascular access device does not have to meet this criterion

• No concurrent major surgery