Irinotecan and Cetuximab With or Without Bevacizumab in Treating Patients With Metastatic Colorectal Cancer That Progressed During First-Line Therapy

Stopped early · Phase 3

Conditions studied: Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IVA Colon Cancer, Stage IVA Rectal Cancer, Stage IVB Colon Cancer, Stage IVB Rectal Cancer

In brief

This randomized phase III trial is studying giving irinotecan and cetuximab together with bevacizumab to see how well it works compared with giving irinotecan and cetuximab alone in treating patients with metastatic colorectal cancer that progressed during first-line therapy. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. It is not yet known whether irinotecan and cetuximab are more effective with or without bevacizumab in treating metastatic colorectal cancer.

Key facts

Study ID

NCT00499369

Run by

National Cancer Institute (NCI)

People needed

72

Starts

2007-06-01

Expected to finish

2012-11-01

Last updated by the study team

2014-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have metastatic colorectal cancer that has been histologically or cytologically confirmed; confirmation may be from either the primary tumor or a metastasis; patients must have wild type KRAS
• Patients must be registered within 28 days of documented disease progression on first line chemotherapy with bevacizumab plus either FOLFOX, OPTIMOX, or XELOX; this progression must have occurred within 90 days after the last dose of bevacizumab; patients who discontinued oxaliplatin, continued with 5-FU/LV or capecitabine and bevacizumab and then had subsequent progression while on fluoropyrimidine and bevacizumab are eligible; patients who discontinued bevacizumab due to adverse events in the first-line setting are not eligible
• Measurable or nonmeasurable disease
• At least 14 days must have elapsed since the last dose of first line chemotherapy and bevacizumab
• Patients must not have received prior treatment with irinotecan (either as adjuvant or metastatic treatment)
• Patients must have no history of prior treatment with cetuximab or other agents targeting VEGF or EGFR (except for bevacizumab)
• Prior radiotherapy is allowed, provided at least 28 days have elapsed since the last treatment; all adverse events related to radiation therapy must be resolved
• Prior surgery is allowed, provided at least 28 days have elapsed since any major surgery and patient has recovered from all effects
• Zubrod performance status 0-2
• Absolute neutrophil count (ANC) >= 1,500/mm\^3
• Platelet count >= 100,000/mm\^3
• Hemoglobin >= 9 g/dL
• Total bilirubin =< 1.5 times upper limit of normal (ULN)
• Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvate transaminase (SGPT) =< 2.5 x IULN; if there are known liver metastases, SGOT or SGPT must be =< 5 x IULN; these results must be obtained within 28 days prior to registration
• Serum creatinine =< IULN or measured or estimated creatinine clearance >= 60 mL/min
• Patients must not have a history or known presence of brain metastasis
• Patients may be on full dose anticoagulation with warfarin provided that the patient has an acceptable International Normalized Ratio (INR) (between 2 and 3), obtained within 28 days prior to registration
• No clinically relevant bleeding diathesis or coagulopathy
• Patients must not have experienced nephrotic range proteinuria from prior bevacizumab therapy; urine protein must be screened by urine analysis for Urine Protein Creatinine (UPC) ratio; for UPC ratio > 0.5, 24-hour urine protein must be obtained and the level must be < 1,000 mg for patient enrollment; urine protein and creatinine used in calculating the UPC ratio must be obtained within 28 days prior to registration
• No uncontrolled high blood pressure (BP) (i.e., systolic BP > 150 mm Hg and diastolic BP > 90 mm Hg)
• No cardiovascular event within the past 6 months, including any of the following:
• Arterial thrombosis
• Unstable angina
• Myocardial infarction
• Cerebrovascular accident

Where it is running

• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States
• East Bay Radiation Oncology Center — Castro Valley, California, United States
• Eden Hospital Medical Center — Castro Valley, California, United States
• Valley Medical Oncology Consultants-Castro Valley — Castro Valley, California, United States
• City of Hope Medical Center — Duarte, California, United States
• Northbay Cancer Center — Fairfield, California, United States
• Valley Medical Oncology Consultants-Fremont — Fremont, California, United States
• Glendale Memorial Hospital and Health Center — Glendale, California, United States
• Marin General Hospital — Greenbrae, California, United States
• Saint Rose Hospital — Hayward, California, United States
• University of Southern California — Los Angeles, California, United States
• Fremont - Rideout Cancer Center — Marysville, California, United States
• Highland General Hospital — Oakland, California, United States
• Alta Bates Summit Medical Center - Summit Campus — Oakland, California, United States
• Bay Area Breast Surgeons Inc — Oakland, California, United States
• Bay Area Tumor Institute CCOP — Oakland, California, United States
• Larry G Strieff MD Medical Corporation — Oakland, California, United States
• Tom K Lee Inc — Oakland, California, United States
• Palchak David MD — Pismo Beach, California, United States
• Valley Care Health System - Pleasanton — Pleasanton, California, United States
• Valley Medical Oncology Consultants — Pleasanton, California, United States
• Sutter Roseville Medical Center — Roseville, California, United States
• UC Davis Comprehensive Cancer Center — Sacramento, California, United States
• Doctors Medical Center- JC Robinson Regional Cancer Center — San Pablo, California, United States
• Saint Edward Mercy Medical Center — Fort Smith, Arkansas, United States

Full record on ClinicalTrials.gov

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