ChronoFOLFOX Plus Avastin for Patients With Metastatic Colorectal Cancer

Phase 2TerminatedNCT00385021

Southwestern Regional Medical Center20 enrolled

Overview

To determine efficacy in the delivery of chronomodulated chemotherapy.

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 the safety of these drugs when given together and the quality of life of the patients who are enrolled in the study. It is thought that these drugs will be better tolerated if they are chronomodulated, i.e., if they are given at certain times of day rather than as a continuous infusion.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colorectal Neoplasms

Interventions

5-Fluorouracil, leucovorin, oxaliplatin, avastinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 86 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cancer Treatment Centers of America at Southwestern Regional Medical Center, Inc.

Tulsa, Oklahoma, United States

Outcomes

Primary Outcomes

The primary objective is to determine if the rate of adverse events among patients receiving chronoFOLFOX plus Avastin is acceptable compared to that in previous studies using the FOLFOX4 regimen.

Time frame: 2 years

Data from ClinicalTrials.gov

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