ChronoFOLFOX Plus Avastin for Patients With Metastatic Colorectal Cancer

• Status: Terminated
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine efficacy in the delivery of chronomodulated chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwestern Regional Medical Center
• Treatments: Bevacizumab; Fluorouracil; Leucovorin; Oxaliplatin

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.