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