Status:
COMPLETED
Bevacizumab and Cetuximab in Combination With FOLFOX6 in Patients With Metastatic Colorectal Cancer
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Colon Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed 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 cetuxima...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00193219
Start Date
July 1 2005
End Date
July 1 2010
Last Update
January 11 2022
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Oncology Hematology Associates of SW Indiana
Evansville, Indiana, United States, 47714
2
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States, 40207
3
Mercy Hospital
Portland, Maine, United States, 04101
4
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817