Combination Chemotherapy in Treating Patients With Transitional Cell Cancer of the Urothelium
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.
Transitional Cell Cancer of the Renal Pelvis and Ureter
Drug: gemcitabine hydrochloride
Drug: vinblastine sulfate
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Randomized Phase II/III Study Assessing Gemcitabine/Carboplatin And Methotrexate/Carboplatin/Vinblastine In Previously Untreated Patients With Advanced Urothelial Cancer Ineligible For Cisplatin Based Chemotherapy|
- Duration of survival [ Designated as safety issue: No ]
- Response as assessed by RECIST criteria [ Designated as safety issue: No ]
- Toxicity as assessed by CTC v2 [ Designated as safety issue: Yes ]
|Study Start Date:||January 2001|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
- 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.
Hide Study Locations
|Salzburg, Austria, A-5020|
|Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital|
|Vienna, Austria, A-1100|
|Onze Lieve Vrouw Ziekenhuis Aalst|
|Aalst, Belgium, B-9300|
|Institut Jules Bordet|
|Brussels, Belgium, 1000|
|Universitair Ziekenhuis Antwerpen|
|Edegem, Belgium, B-2650|
|AZ Groeninge - Oncologisch Centrum|
|Kortrijk, Belgium, 8500|
|Rigshospitalet - Copenhagen University Hospital|
|Copenhagen, Denmark, 2100|
|Klinikum Nuernberg - Klinikum Nord|
|Nuernberg, Germany, D-90419|
|National Institute of Oncology|
|Budapest, Hungary, 1125|
|Assaf Harofeh Medical Center|
|Zerifin, Israel, 70300|
|Universita Di Palermo|
|Palermo, Italy, 90145|
|Ospedale di Circolo e Fondazione Macchi|
|Varese, Italy, 21100|
|Jeroen Bosch Ziekenhuis|
|'s-Hertogenbosch, Netherlands, 5211 NL|
|Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital|
|Amsterdam, Netherlands, 1066 CX|
|Academisch Medisch Centrum at University of Amsterdam|
|Amsterdam, Netherlands, 1105 AZ|
|Leiden University Medical Center|
|Leiden, Netherlands, 2300 CA|
|Universitair Medisch Centrum St. Radboud - Nijmegen|
|Nijmegen, Netherlands, NL-6500 HB|
|University Medical Center Rotterdam at Erasmus Medical Center|
|Rotterdam, Netherlands, 3000 CA|
|University Medical Center Utrecht|
|Utrecht, Netherlands, 3584 CX|
|Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology|
|Warsaw, Poland, 02-781|
|Hospital Clinic de Barcelona|
|Barcelona, Spain, 08036|
|Hospital de la Santa Cruz i Sant Pau|
|Barcelona, Spain, 08025|
|Vall d'Hebron University Hospital|
|Barcelona, Spain, 08035|
|Hospital Universitario San Carlos|
|Madrid, Spain, 28040|
|Instituto Valenciano De Oncologia|
|Valencia, Spain, 46009|
|Southampton General Hospital|
|Southampton, England, United Kingdom, SO16 6YD|
|Leeds Cancer Centre at St. James's University Hospital|
|Southampton, England, United Kingdom, SO14 0YG|
|Royal South Hants Hospital|
|Southampton, England, United Kingdom, SO14 0YG|
|Royal Marsden - Surrey|
|Sutton, England, United Kingdom, SM2 5PT|
|Study Chair:||Gerwin Kaiser, MD||Klinikum Nuernberg - Klinikum Nord|