NCT00003133

Combination Chemotherapy Following Surgery in Treating Patients With Advanced Bladder Cancer

Sequential Gemcitabine, Doxorubicin, Then Paclitaxel Plus Cisplatin Adjuvant Chemotherapy After Complete Resection of Locally Advanced Transitional Cell Carcinoma of the Urothelium

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · 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 following surgery in treating patients with advanced bladder cancer.

Detailed description

OBJECTIVES: I. Determine the safety and toxicity of sequential dose intensive adjuvant systemic therapy consisting of gemcitabine, then doxorubin, followed by paclitaxel and cisplatin with filgrastim (granulocyte colony stimulating factor; G-CSF) for patients with completely resected, locally advanced transitional cell carcinoma of the urothelium. II. Assess the disease free and overall survival of these patients. OUTLINE: Patients receive gemcitabine IV on weeks 1, 2, 3, 5, 6, and 7 for a total of 6 doses. A 1 week rest period occurs after the third dose of gemcitabine. At least 14 days after the last dose of gemcitabine, during the ninth week, patients receive doxorubicin at 2 week intervals (weeks 9, 11, 13, and 15) for a total of 4 doses. Filgrastim (granulocyte colony stimulating factor; G-CSF) is administered subcutaneously on days 3-10 of each cycle of doxorubicin. At least 14 days after the last dose of doxorubicin, during week 17, patients receive the combination of paclitaxel IV (3 hour infusion) and cisplatin, at 2 week intervals (weeks 17, 19, 21, and 23) for a total of 4 doses. G-CSF is again administered on days 3-10 of each of these cycles. Patients are followed every 3 months for the first 2 years, every 6 months for the next 3 years, then annually until death. PROJECTED ACCRUAL: This study will accrue 25-30 patients in 1.5-2 years.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim
DRUG	cisplatin
DRUG	doxorubicin hydrochloride
DRUG	gemcitabine hydrochloride
DRUG	paclitaxel

Timeline

• Start date: 1997-09-01
• Primary completion: 2003-01-01
• Completion: 2003-01-01
• First posted: 2004-04-30
• Last updated: 2013-06-28

Locations

1 site across 1 country: United States