Colon Cancer Clinical Trial

Bevacizumab and Cetuximab in Combination With FOLFOX6 in Patients With Metastatic Colorectal Cancer

Summary

This trial will evaluate the combination of modified infusional 5-fluorouracil/ leucovorin, oxaliplatin (FOLFOX6), bevacizumab, and cetuximab in patients with metastatic colorectal cancer. FOLFOX6 has proven to be a safe and effective regimen in first line treatment of advanced colorectal cancer. The role of epidermal growth factor (EGFR) inhibitors in an earlier treatment setting in combination with optimal chemotherapy regimens is an important emerging question.

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Full Description

All patients received cetuximab: 400 mg/m2 (first cycle only) administered intravenously (IV) on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8. Day 1 cetuximab was immediately followed by bevacizumab 5 mg/kg IV, oxaliplatin 85 mg/m2 IV, and 5-fluorouracil 400 mg/m2 IV bolus, followed by 2400 mg/m2 administered as a continuous infusion over 46 hours via a pump (outpatient) and leucovorin 350 mg IV (modified FOLFOX6). Cycles were 14 days.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

To be included in the study, you must meet the following criteria:

Metastatic colorectal cancer confirmed by a biopsy sample
18 years of age or older
Evidence of disease progression at time of study entry
At least one prior adjuvant chemotherapy regimen
No prior therapy for metastatic disease
Measurable disease
Able to perform activities of daily living with minimal assistance
Adequate bone marrow, kidney, and liver function
Tumor tissue available for assessment of EGFR
Signed informed consent

Exclusion Criteria:

You cannot participate in the study if any of the following apply to you:

Treatment with a previous regimen for metastatic disease
Prior treatment with any EGFR inhibitor or anti-angiogenic agents
Brain or nervous system metastases
History of severe thromboembolic event
Clinical evidence or history of bleeding or coagulopathy
History of stroke or heart attack within six months
Poorly controlled hypertension
Non-healing wound, ulcer, or bone fracture
History of abdominal fistula, perforation, or abscess within six months
Other uncontrolled or significant disease or medical condition

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

36

Study ID:

NCT00193219

Recruitment Status:

Completed

Sponsor:

SCRI Development Innovations, LLC

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There are 10 Locations for this study

See Locations Near You

Oncology Hematology Associates of SW Indiana
Evansville Indiana, 47714, United States
Consultants in Blood Disorders and Cancer
Louisville Kentucky, 40207, United States
Mercy Hospital
Portland Maine, 04101, United States
Center for Cancer and Blood Disorders
Bethesda Maryland, 20817, United States
Jackson Oncology Associates
Jackson Mississippi, 39202, United States
St. Louis Cancer Care
Chesterfield Missouri, 63017, United States
Methodist Cancer Center
Omaha Nebraska, 68114, United States
Oncology Hematology Care
Cincinnati Ohio, 45242, United States
Chattanooga Oncology and Hematology Associates
Chattanooga Tennessee, 37404, United States
Tennessee Oncology
Nashville Tennessee, 37203, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

36

Study ID:

NCT00193219

Recruitment Status:

Completed

Sponsor:


SCRI Development Innovations, LLC

How clear is this clinincal trial information?

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