Cisplatin Plus Gemcitabine With or Without Paclitaxel in Treating Patients With Stage IV Urinary Tract Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective for urinary tract cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin plus gemcitabine with or without paclitaxel in treating patients who have stage IV urinary tract cancer.
Transitional Cell Cancer of the Renal Pelvis and Ureter
Drug: gemcitabine hydrochloride
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Phase III Study Comparing Paclitaxel/Cisplatin/Gemcitabine and Cisplatin/Gemcitabine in Patients With Metastatic or Locally Advanced Urothelial Cancer Without Prior Systemic Therapy|
|Study Start Date:||May 2001|
|Primary Completion Date:||June 2004 (Final data collection date for primary outcome measure)|
- Compare the duration of survival of patients with stage IV transitional cell carcinoma of the urothelium treated with cisplatin and gemcitabine with or without paclitaxel.
- Compare the duration of progression-free survival, response rates, and duration of response in patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center, WHO performance status (0 vs 1), and presence of metastatic disease (yes vs no). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and cisplatin IV over 1 hour on day 1 or 2. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive paclitaxel IV over 1 hour on days 1 and 8 followed by cisplatin IV over 1 hour on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for at least 3 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 610 patients (305 per treatment arm) will be accrued for this study within 3.04 years.
Show 234 Study Locations
|Study Chair:||Joaquim Bellmunt, MD, PhD||Vall d'Hebron University Hospital|
|Study Chair:||Stephane Culine, MD||Centre Val d'Aurelle - Paul Lamarque|
|Study Chair:||Michael Leahy, MBChB, FRACP, FRCP, FRC Path||Fremantle Hospital|
|Study Chair:||Christoph Zielinski, MD||Allgemeines Krankenhaus - Universitatskliniken|
|Study Chair:||Malcolm J. Moore, MD||Princess Margaret Hospital, Canada|
|Study Chair:||David C. Smith, MD||University of Michigan Cancer Center|
|Study Chair:||Andreas Boehle, MD||Universitaetsklinikum Schleswig-Holstein - Campus Luebeck|
|Study Chair:||Jose Baselga, MD||Vall d'Hebron University Hospital|