ChronoFOLFOX Plus Avastin for Patients With Metastatic Colorectal Cancer

This study has been terminated.

First Received: October 4, 2006 Last Updated: October 31, 2007 History of Changes

Sponsored by:	Southwestern Regional Medical Center
Information provided by:	Southwestern Regional Medical Center
ClinicalTrials.gov Identifier:	NCT00385021

Purpose

To determine efficacy in the delivery of chronomodulated chemotherapy.

Condition	Intervention	Phase
Colorectal Neoplasms	Drug: 5-Fluorouracil, leucovorin, oxaliplatin, avastin	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title:	ChronoFOLFOX Plus Avastin for Patients With Metastatic Colorectal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Fluorouracil Leucovorin Oxaliplatin Bevacizumab

U.S. FDA Resources

Further study details as provided by Southwestern Regional Medical Center:

Primary Outcome Measures:

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 ]

Estimated Enrollment:	20
Study Start Date:	October 2006
Study Completion Date:	September 2007

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.

Eligibility

Ages Eligible for Study:	18 Years to 86 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00385021

Locations

United States, Oklahoma
Cancer Treatment Centers of America at Southwestern Regional Medical Center, Inc.
Tulsa, Oklahoma, United States, 74133

Sponsors and Collaborators

Southwestern Regional Medical Center

Investigators

Principal Investigator:

Petra Ketterl, MD

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

More Information

Additional Information:

Click here for more information about this study: ChronoFOLFOX Plus Avastin for Patients With Metastatic Colorectal Cancer This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CTCT 06-06
Study First Received:	October 4, 2006
Last Updated:	October 31, 2007
ClinicalTrials.gov Identifier:	NCT00385021 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Southwestern Regional Medical Center:

Advanced
metastatic
colorectal
cancer
Avastin

Study placed in the following topic categories:

Antimetabolites
Digestive System Neoplasms
Immunologic Factors
Gastrointestinal Diseases
Colonic Diseases
Leucovorin
Bevacizumab
Folinic Acid
Intestinal Diseases

Angiogenesis Inhibitors
Immunosuppressive Agents
Rectal Diseases
Intestinal Neoplasms
Oxaliplatin
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Gastrointestinal Diseases
Antineoplastic Agents
Colonic Diseases
Physiological Effects of Drugs
Bevacizumab
Rectal Diseases
Neoplasms by Site
Therapeutic Uses
Growth Inhibitors

Angiogenesis Modulating Agents
Digestive System Neoplasms
Growth Substances
Intestinal Diseases
Immunosuppressive Agents
Angiogenesis Inhibitors
Intestinal Neoplasms
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on September 03, 2009