Bevacizumab and Cetuximab in Combination With FOLFOX6 in Patients With Metastatic Colorectal Cancer
Completed · Phase 2
Conditions studied: Colon Cancer
In brief
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.
Key facts
- Study ID
- NCT00193219
- Run by
- SCRI Development Innovations, LLC
- People needed
- 36
- Starts
- 2005-07-01
- Expected to finish
- 2010-07-01
- Last updated by the study team
- 2022-01-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Oncology Hematology Associates of SW Indiana — Evansville, Indiana, United States
- Consultants in Blood Disorders and Cancer — Louisville, Kentucky, United States
- Mercy Hospital — Portland, Maine, United States
- Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
- Jackson Oncology Associates — Jackson, Mississippi, United States
- St. Louis Cancer Care — Chesterfield, Missouri, United States
- Methodist Cancer Center — Omaha, Nebraska, United States
- Oncology Hematology Care — Cincinnati, Ohio, United States
- Chattanooga Oncology and Hematology Associates — Chattanooga, Tennessee, United States
- Tennessee Oncology — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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