A Phase II Trial of "Sequential Doublets" Chemotherapy in Patients With Locally Advanced or Metastatic Bladder Cancer
- Determine the response rate to the combination of docetaxel and methotrexate followed
by gemcitabine and cisplatin in patients with stage IV locally advanced or metastatic,
previously untreated, transitional cell carcinoma of the urothelium.
- Assess the toxicities of this sequential regimen in this patient population.
- Assess time to event efficacy measures including time to disease progression, duration
of response, and overall survival in these patients treated with this sequential
OUTLINE: Patients receive methotrexate IV on days 1 and 8 and docetaxel IV over 1 hour on
day 8 every 3 weeks for 9 weeks. Patients then receive cisplatin IV over 2 hours on day 1
and gemcitabine IV over 100 minutes on days 1 and 8 every 3 weeks for 9 weeks. This 18 week
sequential regimen constitutes 1 full course. Treatment continues in the absence of
unacceptable toxicity or disease progression.
Patients are followed until death or until 2 years after study entry, whichever comes first.
PROJECTED ACCRUAL: A total of 18-46 patients will be accrued for this study within 9-24
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety and toxic effects of giving docetaxel and methotrexate followed by gemcitabine and cisplatin
Walter M. Stadler, MD, FACP
University of Chicago
United States: Federal Government
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|Louis A. Weiss Memorial Hospital||Chicago, Illinois 60640|
|Oncology/Hematology Associates of Central Illinois, P.C.||Peoria, Illinois 61602|
|Fort Wayne Medical Oncology and Hematology, Inc.||Fort Wayne, Indiana 46885-5099|