Combination Chemotherapy in Treating Patients With Stage IV Locally Advanced or Metastatic Bladder Cancer
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.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have stage IV locally advanced or metastatic bladder cancer.
Drug: gemcitabine hydrochloride
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of "Sequential Doublets" Chemotherapy in Patients With Locally Advanced or Metastatic Bladder Cancer|
- Safety and toxic effects of giving docetaxel and methotrexate followed by gemcitabine and cisplatin [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 1999|
|Study Completion Date:||April 2005|
|Primary Completion Date:||August 2002 (Final data collection date for primary outcome measure)|
Experimental: Arm A
Methotrexate will be given as a short infusion (introduced into a vein) for approximately 5 minutes on the first day (day 1). ). A week later (day 8), both methotrexate and docetaxel will be given the same way, but this will take about 1 hour. The first course of treatment consists of receiving treatment on day 1 and day 8 every 21 days for 9 weeks. X-rays or scans will then be performed to determine if your tumor is shrinking. You will then start treatment with gemcitabine and cisplatin. On the first day (day 1), you will receive both cisplatin and gemcitabine into your vein. A week later (day 8), you will receive only gemcitabine as an infusion into your vein over 100 minutes and no additional intravenous fluid will be required on that day. This second course of treatment consists of receiving treatment on day 1 and day 8 every 21 days for 9 weeks.
|Drug: cisplatin Drug: docetaxel Drug: gemcitabine hydrochloride Drug: methotrexate|
- 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 regimen.
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 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005086
|United States, Illinois|
|Louis A. Weiss Memorial Hospital|
|Chicago, Illinois, United States, 60640|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|Oncology/Hematology Associates of Central Illinois, P.C.|
|Peoria, Illinois, United States, 61602|
|United States, Indiana|
|Fort Wayne Medical Oncology and Hematology, Inc.|
|Fort Wayne, Indiana, United States, 46885-5099|
|Study Chair:||Walter M. Stadler, MD, FACP||University of Chicago|