NCT00310011

Gemcitabine, Paclitaxel, and Cisplatin in Treating Patients With Advanced Cancer of the Urothelium

A Phase II Trial of Gemzar (Gemcitabine), Taxol (Paclitaxel), and Platinol (Cisplatin) (GTP) in Treatment of Advanced Transitional Cell Carcinoma of the Urothelium

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, paclitaxel, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with paclitaxel and cisplatin works in treating patients with advanced transitional cell cancer of the urothelium.

Detailed description

OBJECTIVES: * Determine response to gemcitabine hydrochloride, paclitaxel, and cisplatin (GTP) among patients with regional or distant metastases of transitional cell carcinoma of the urothelium or local/regional recurrence after cystoprostatectomy. * Determine response in patients who receive GTP as the initial chemotherapeutic treatment as well as in patients who have received prior chemotherapy. * Determine response duration, freedom from progression, and overall survival. * Assess the toxicity of GTP. OUTLINE: This is an open-label study. Patients are stratified according to prior chemotherapy (yes vs no). Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a partial response or complete response undergo surgical restaging and debulking. Four to 6 weeks later, patients receive 2 additional courses of chemotherapy. After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study.

Conditions

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

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	gemcitabine hydrochloride
DRUG	paclitaxel
PROCEDURE	conventional surgery

Timeline

• Start date: 1998-06-01
• Primary completion: 2005-10-01
• Completion: 2009-08-01
• First posted: 2006-04-03
• Last updated: 2018-08-10

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study