Gemcitabine, Cisplatin, and Celecoxib Treatment of Metastatic Pancreatic Cancer

Phase 2

Completed

• Conditions: Pancreatic Cancer

• Registration Number: NCT00176813
• Lead Sponsor: University of Michigan Rogel Cancer Center

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2003-03
• Primary Completion: 2003-11
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-15
• Study Completion: 2006-11
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-29
• Last Update Posted: 2008-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To determine the overall survival time in patients with metastatic pancreatic cancer treated with the combination of gemcitabine, cisplatin and celecoxib.	12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States