Status:
TERMINATED
ChronoFOLFOX Plus Avastin for Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Southwestern Regional Medical Center
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
18-86 years
Phase:
PHASE2
Brief Summary
To determine efficacy in the delivery of chronomodulated chemotherapy.
Detailed Description
The purpose of this study is to determine if treatment with 5-Fluorouracil, leucovorin, oxaliplatin, and Avastin will cause colorectal tumor cells to shrink or disappear. The study will also determine...
Eligibility Criteria
Inclusion
- Histological proof of adenocarcinoma in primary colon or rectum tumor.
- Evidence of metastatic colorectal cancer or loco-regional recurrence or unresectable disease.
- Ages 18 to 86 years.
- Presence of at least one bi-dimensionally measurable disease with at least one diameter \> or = 2 cm.
- WHO/ECOG performance status \< 3 (0, 1, or 2)
- Prior treatment with oxaliplatin, 5-FU, or leucovorin permitted.
- Signed informed consent
Exclusion
- Peripheral sensory neuropathy \> or = grade 3.
- Serum bilirubin (total) \> 3 X ULN.
- Symptomatic or uncontrolled brain metastasis.
- Metastases limited to bone, pleural effusion, or ascites.
- Uncontrolled overt cardiac disease.
- Uncontrolled hypercalcemia.
- Uncontrolled infections.
- Uncontrolled hypertension (\>180/110)
- History of GI perforation.
- History of arterial thromboembolic events.
- History of congestive heart failure.
- Patients taking warfarin (Coumadin).
- Patients who are pregnant.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00385021
Start Date
October 1 2006
End Date
September 1 2007
Last Update
November 2 2007
Active Locations (1)
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1
Cancer Treatment Centers of America at Southwestern Regional Medical Center, Inc.
Tulsa, Oklahoma, United States, 74133