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Clinical Trials/NCT00176813
NCT00176813
Completed
Phase 2

Phase II Study of Gemcitabine, Cisplatin, and Celecoxib in the Treatment of Metastatic Pancreatic Cancer

University of Michigan Rogel Cancer Center1 site in 1 country5 target enrollmentMarch 2003

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Pancreatic Cancer
Sponsor
University of Michigan Rogel Cancer Center
Enrollment
5
Locations
1
Primary Endpoint
To determine the overall survival time in patients with metastatic pancreatic cancer treated with the combination of gemcitabine, cisplatin and celecoxib.
Status
Completed
Last Updated
18 years ago

Overview

Brief Summary

This study will examine an investigational (experimental) treatment using gemcitabine, cisplatin, and celecoxib. Preliminary studies have shown that this experimental treatment may be effective in reducing the size of cancerous tumors and/or preventing further tumor growth.

This is a phase II clinical trial studying the reactions of the patient's body and their tumor to the combination of gemcitabine, cisplatin, and celecoxib. The purpose of this study is to see if the tumor responds to this treatment and to determine how long the response lasts. This study will also look at what kind of side effects this experimental treatment causes and see how often these side effects occur. Blood levels of celecoxib will be measured to find out how this treatment affects factors (proteins) involved in new blood vessel formation and tumor growth (angiogenesis).

Registry
clinicaltrials.gov
Start Date
March 2003
End Date
November 2006
Last Updated
18 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

To determine the overall survival time in patients with metastatic pancreatic cancer treated with the combination of gemcitabine, cisplatin and celecoxib.

Time Frame: 12 months

Secondary Outcomes

  • To obtain data on overall time to disease progression(12 months)
  • To determine time to treatment failure(12 months)
  • To determine the tolerability of celecoxib with gemcitabine and cisplatin.(12 months)
  • To characterize the nature of the toxicity for this combination in this patient group.(12 months)
  • To determine objective tumor response(12 months)
  • To determine the influence of therapy on the blood levels of prostaglandins and angiogenesis(12 months)

Study Sites (1)

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