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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

October 4, 2006
October 31, 2007
October 2006
Not Provided
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 ]
Efficacy of these drugs used in combination.
Complete list of historical versions of study NCT00385021 on ClinicalTrials.gov Archive Site
Not Provided
  • Safety.
  • Toxicities.
  • Quality of life.
Not Provided
Not Provided
 
ChronoFOLFOX Plus Avastin for Patients With Metastatic Colorectal Cancer
ChronoFOLFOX Plus Avastin for Patients With Metastatic Colorectal Cancer

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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Neoplasms
Drug: 5-Fluorouracil, leucovorin, oxaliplatin, avastin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
September 2007
Not Provided

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.
Both
18 Years to 86 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00385021
CTCT 06-06
No
Not Provided
Southwestern Regional Medical Center
Not Provided
Principal Investigator: Petra Ketterl, MD Cancer Treatment Centers of America at Southwestern Regional Medical Center, Inc.
Southwestern Regional Medical Center
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP