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ChronoFOLFOX Plus Avastin for Patients With Metastatic Colorectal Cancer

This study has been terminated.
Sponsor:
Information provided by:
Southwestern Regional Medical Center
ClinicalTrials.gov Identifier:
NCT00385021
First received: October 4, 2006
Last updated: October 31, 2007
Last verified: October 2007
History of Changes
  Purpose

To determine efficacy in the delivery of chronomodulated chemotherapy.


Condition Intervention Phase
Colorectal Neoplasms
 Drug: 5-Fluorouracil, leucovorin, oxaliplatin, avastin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ChronoFOLFOX Plus Avastin for Patients With Metastatic Colorectal Cancer

Resource links provided by NLM:

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

No publications provided

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

Keywords provided by Southwestern Regional Medical Center:
Advanced
metastatic
colorectal
cancer
Avastin

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fluorouracil
Oxaliplatin
Bevacizumab
Leucovorin
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Angiogenesis Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on May 19, 2013