NCT00004223

Docetaxel and Gemcitabine in Treating Patients With Progressive Regional or Metastatic Bladder Cancer

Phase II Trial of Gemcitabine and Docetaxel in Advanced Carcinoma of the Urothelium

• 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 than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of docetaxel and gemcitabine in treating patients who have progressive regional or metastatic bladder cancer.

Detailed description

OBJECTIVES: I. Determine the response rate of patients with progressive regional or metastatic transitional cell carcinoma of the urothelium and failure of only 1 prior systemic regimen treated with docetaxel and gemcitabine. II. Determine the toxicities of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour followed by gemcitabine IV over 30 minutes on days 1 and 8. For patients with complete or partial response or stable disease at 3 weeks, treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months through year 2, every 6 months through year 5, and then annually thereafter until disease progression. PROJECTED ACCRUAL: A total of 22-45 patients will be accrued for this study over 18-21 months.

Conditions

• Bladder Cancer
• Transitional Cell Cancer of the Renal Pelvis and Ureter
• Urethral Cancer

Interventions

Type	Name	Description
DRUG	docetaxel
DRUG	gemcitabine hydrochloride

Timeline

• Start date: 2000-02-24
• Primary completion: 2002-10-01
• First posted: 2004-02-25
• Last updated: 2023-06-18

Locations

76 sites across 3 countries: United States, Puerto Rico, South Africa