ChronoFOLFOX Plus Avastin for Patients With Metastatic Colorectal Cancer

Stopped early · Phase 2

Conditions studied: Colorectal Neoplasms

In brief

To determine efficacy in the delivery of chronomodulated chemotherapy.

Key facts

Study ID

NCT00385021

Run by

Southwestern Regional Medical Center

People needed

20

Starts

2006-10-01

Expected to finish

2007-09-01

Last updated by the study team

2007-11-02

Who can join

Age: 18 and older, up to 86. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Cancer Treatment Centers of America at Southwestern Regional Medical Center, Inc. — Tulsa, Oklahoma, United States

Full record on ClinicalTrials.gov

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