Combination Chemotherapy Treatments in Patients With Metastatic Colorectal Cancer

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT00230399
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Celecoxib — DRUG
  • Capecitabine — DRUG
  • Irinotecan — DRUG

Study Details

This study will examine a new combination of drugs: celecoxib, capecitabine and irinotecan, for the treatment of metastatic colorectal cancer. Capecitabine and irinotecan, individually, are approved by the Food and Drug Administration (FDA) for use in colorectal cancer. The combination of these two drugs is experimental (not approved by the FDA as standard treatment), but is a widely used treatment option and preliminary studies have shown that treatment with the combination of capecitabine and irinotecan has a positive effect on metastatic colorectal cancer. Likewise, previous research in animals has shown that celecoxib, a drug approved for arthritis therapy, also has activity against this tumor type and may improve the anti-cancer activity of the combination of capecitabine and irinotecan.

Key Dates

Start date
Jun 30, 2003
Status verified
Apr 2015
Primary completion
Jan 31, 2006
Completion
Mar 31, 2008

Study Design

Enrollment
15 participants
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Primary Outcome Measure

To determine the objective response rate to the combination of celecoxib, capecitabine, and irinotecan in patients with metastatic colorectal cancer.

Locations (1)

FacilityCityStateZIPSite coordinators
University of Michigan Cancer CenterAnn ArborMichigan48109-

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