NCT00004003

Combination Chemotherapy in Treating Patients With Stage III or Stage IV Pancreatic Cancer That Cannot Be Removed by Surgery

A Study of Gemcitabine, Cisplatin, and 5-Fluorouracil in the Treatment of Advanced Pancreatic Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating adult patients who have stage III or stage IV pancreatic cancer that cannot be removed by surgery.

Detailed description

OBJECTIVES: I. Determine the overall survival in patients with unresectable stage III or IV pancreatic adenocarcinoma treated with gemcitabine, cisplatin, and fluorouracil. II. Determine the resectability rate with curative intent in patients with unresectable stage III pancreatic adenocarcinoma treated with this regimen. III. Assess the tolerability and toxicity of this treatment regimen in this patient population. IV. Evaluate this regimen in terms of response rate, response duration, and overall time to disease progression in these patients. V. Evaluate the quality of life in these patients. OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15, followed by cisplatin IV over 30 minutes on days 1 and 15. Patients receive fluorouracil as a continuous infusion on days 1-15. Courses repeat every 28 days. Quality of life is assessed every 28 days. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	fluorouracil
DRUG	gemcitabine hydrochloride

Timeline

• Start date: 1999-04-01
• Primary completion: 2001-11-01
• Completion: 2003-08-01
• First posted: 2004-02-12
• Last updated: 2013-04-05

Locations

1 site across 1 country: United States