ChronoFOLFOX Plus Avastin for Patients With Metastatic Colorectal Cancer

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00385021

Enrollment

Registered

2006-10-06

Start date

2006-10-31

Completion date

2007-09-30

Last updated

2007-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Neoplasms

Keywords

Advanced, metastatic, colorectal, cancer, Avastin

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 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.

Interventions

DRUG5-Fluorouracil, leucovorin, oxaliplatin, avastin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 86 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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.	2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026