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
- 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
- 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
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.
Allocation: Randomized, Primary Purpose: Treatment
Duration of survival
Gerwin Kaiser, MD
Klinikum Nuernberg - Klinikum Nord
United States: Federal Government