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ChronoFOLFOX Plus Avastin for Patients With Metastatic Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00385021
Recruitment Status : Terminated
First Posted : October 6, 2006
Last Update Posted : November 2, 2007
Information provided by:
Southwestern Regional Medical Center

Brief Summary:
To determine efficacy in the delivery of chronomodulated chemotherapy.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Drug: 5-Fluorouracil, leucovorin, oxaliplatin, avastin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ChronoFOLFOX Plus Avastin for Patients With Metastatic Colorectal Cancer
Study Start Date : October 2006
Actual Study Completion Date : September 2007

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 86 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00385021

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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
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Principal Investigator: Petra Ketterl, MD Cancer Treatment Centers of America at Southwestern Regional Medical Center, Inc.
Additional Information:
Layout table for additonal information Identifier: NCT00385021    
Other Study ID Numbers: CTCT 06-06
First Posted: October 6, 2006    Key Record Dates
Last Update Posted: November 2, 2007
Last Verified: October 2007
Keywords provided by Southwestern Regional Medical Center:
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Protective Agents
Vitamin B Complex