NCT00003810

Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas

A Phase II Study of Gemcitabine and Docetaxel in Pancreatic Adenocarcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Eastern Cooperative Oncology Group · Network
• Sex: All
• Age: 18 Years – 120 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 that one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and docetaxel in treating patients who have locally advanced or metastatic cancer of the pancreas.

Detailed description

OBJECTIVES: I. Determine the objective response rate of patients with pancreatic adenocarcinoma treated with combination gemcitabine and docetaxel. II. Determine the toxicity profile of this combination therapy in these patients. III. Assess the survival rate of these patients. OUTLINE: Patients receive docetaxel IV over 1 hour followed by gemcitabine IV over 30 minutes. Patients receive treatment every other week for 8 weeks (4 courses). Patients may continue treatment in the absence of unacceptable toxicity or disease progression. Patients are followed every 12 weeks until death. PROJECTED ACCRUAL: This study will accrue approximately 10 patients per month for a maximum of 33 patients.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	docetaxel
DRUG	gemcitabine hydrochloride

Timeline

• Start date: 1999-08-11
• Primary completion: 2002-05-01
• First posted: 2004-08-04
• Last updated: 2023-06-15

Locations

10 sites across 1 country: United States