Combination Chemotherapy in Treating Patients With Transitional Cell Cancer of the Urothelium
- Conditions
- Bladder CancerTransitional Cell Cancer of the Renal Pelvis and UreterUrethral Cancer
- Registration Number
- NCT00014274
- Brief 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. It is not yet known which combination chemotherapy regimen is most effective for transitional cell cancer of the urothelium.
PURPOSE: Randomized phase II/III trial to compare different combination chemotherapy regimens in treating patients who have transitional cell cancer of the urothelium.
- Detailed Description
OBJECTIVES:
* Compare the antitumor activity of gemcitabine and carboplatin vs methotrexate, carboplatin, and vinblastine in patients with transitional cell cancer of the urothelium who are ineligible for cisplatin-based chemotherapy.
* Compare the toxicity and acute and intermediate (1-2 years) side effects of these regimens in these patients.
* Compare the complete response rates, progression-free survival, and overall survival of patients treated with these regimens.
* Compare the symptoms and quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.
* Arm I: Patients receive methotrexate\* IV and vinblastine IV on days 1, 15, and 22 and carboplatin IV over 1 hour on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
NOTE: \* Methotrexate is omitted for patients with pleural effusion or ascites until complete resolution and for patients with a glomerular filtration rate less than 30 mL/min or creatinine greater than 2 mg/dL
Patients in either arm who achieve a complete response (CR) receive 2 additional courses of chemotherapy beyond CR.
Quality of life is assessed at baseline, after every 2 courses of chemotherapy, and within 6 weeks of completion of therapy.
Patients are followed within 6 weeks, every 3 months for 1 year, and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 156 patients (78 per treatment arm) will be accrued for the phase II portion of this study. A total of 225 patients will be accrued for the phase II + III portions of this study within 5 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 238
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of survival
- Secondary Outcome Measures
Name Time Method Response as assessed by RECIST criteria Toxicity as assessed by CTC v2
Trial Locations
- Locations (29)
Academisch Medisch Centrum at University of Amsterdam
🇳🇱Amsterdam, Netherlands
Institut Jules Bordet
🇧🇪Brussels, Belgium
Universitair Medisch Centrum St. Radboud - Nijmegen
🇳🇱Nijmegen, Netherlands
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
AZ Groeninge - Oncologisch Centrum
🇧🇪Kortrijk, Belgium
Universita Di Palermo
🇮🇹Palermo, Italy
Hospital Universitario San Carlos
🇪🇸Madrid, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Onze Lieve Vrouw Ziekenhuis Aalst
🇧🇪Aalst, Belgium
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
🇳🇱Amsterdam, Netherlands
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Klinikum Nuernberg - Klinikum Nord
🇩🇪Nuernberg, Germany
Jeroen Bosch Ziekenhuis
🇳🇱's-Hertogenbosch, Netherlands
University Medical Center Rotterdam at Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
Ospedale di Circolo e Fondazione Macchi
🇮🇹Varese, Italy
Hospital de la Santa Cruz i Sant Pau
🇪🇸Barcelona, Spain
Vall d'Hebron University Hospital
🇪🇸Barcelona, Spain
Assaf Harofeh Medical Center
🇮🇱Zerifin, Israel
Instituto Valenciano De Oncologia
🇪🇸Valencia, Spain
Rigshospitalet - Copenhagen University Hospital
🇩🇰Copenhagen, Denmark
Royal Marsden - Surrey
🇬🇧Sutton, England, United Kingdom
Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital
🇦🇹Vienna, Austria
Southampton General Hospital
🇬🇧Southampton, England, United Kingdom
St. Johanns-Spital
🇦🇹Salzburg, Austria
National Institute of Oncology
ðŸ‡ðŸ‡ºBudapest, Hungary
Leeds Cancer Centre at St. James's University Hospital
🇬🇧Southampton, England, United Kingdom
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
🇵🇱Warsaw, Poland
Royal South Hants Hospital
🇬🇧Southampton, England, United Kingdom
University Medical Center Utrecht
🇳🇱Utrecht, Netherlands