NCT00004884

Docetaxel and Gemcitabine Compared With Docetaxel and Cisplatin in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer

Randomized Phase II Study of Docetaxel/Gemcitabine vs. Docetaxel/Cisplatin in Metastatic or Locoregionally Advanced Pancreatic Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• 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. It is not yet known whether docetaxel plus gemcitabine is more effective than docetaxel plus cisplatin in treating advanced pancreatic cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of docetaxel and gemcitabine with that of docetaxel and cisplatin in treating patients who have metastatic or locally advanced pancreatic cancer.

Detailed description

OBJECTIVES: I. Assess the efficacy of docetaxel and gemcitabine vs docetaxel and cisplatin in patients with metastatic or locoregionally advanced pancreatic cancer. II. Assess the toxicity, response rate, duration of response, time to progression, survival, performance status, and weight associated with these treatment regimens in these patients. OUTLINE: This is a randomized, open label, multicenter study. Patents are randomized to one of two treatment arms. Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Arm II: Patients receive docetaxel IV over 1 hour followed by cisplatin IV over 1 hour on day 1. Treatment is repeated every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks until disease progression, and then every 8 weeks until death. PROJECTED ACCRUAL: Up to 82 patients (41 per arm) will be accrued for this study.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	docetaxel
DRUG	gemcitabine hydrochloride

Timeline

• Start date: 1999-07-01
• Primary completion: 2001-03-01
• First posted: 2004-05-03
• Last updated: 2012-09-24

Locations

19 sites across 8 countries: Belgium, Egypt, France, Germany, Netherlands, Poland, Turkey (Türkiye), United Kingdom