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NCT00385021
ChronoFOLFOX Plus Avastin for Patients With Metastatic Colorectal Cancer
Archived
Phase 2
Description
To determine efficacy in the delivery of chronomodulated chemotherapy.
Documented evidence
Published efficacy for this trial's target/drug in colorectal cancer. It refers to the drug or molecular target, not to this specific trial, and does not confirm eligibility. Always review with your oncologist.
No documented evidence yet in our database for this trial's target or drug. This section grows as new publications are processed.
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Trial Information
NCT00385021
Archived
Phase 2
20 participants
Oct 2006
Locations1
United States (1)
Cancer Treatment Centers of America at Southwestern Regional Medical Center, Inc.
Tulsa, Oklahoma, 74133