Bladder Cancer Clinical Trial
Official title:
Randomized Phase III Study Comparing Paclitaxel/Cisplatin/Gemcitabine and Cisplatin/Gemcitabine in Patients With Metastatic or Locally Advanced Urothelial Cancer Without Prior Systemic Therapy
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. It is not yet known which combination chemotherapy regimen is
more effective for urinary tract cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin plus
gemcitabine with or without paclitaxel in treating patients who have stage IV urinary tract
cancer.
OBJECTIVES:
- Compare the duration of survival of patients with stage IV transitional cell carcinoma
of the urothelium treated with cisplatin and gemcitabine with or without paclitaxel.
- Compare the duration of progression-free survival, response rates, and duration of
response in patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to participating center, WHO performance status (0 vs 1), and presence of
metastatic disease (yes vs no). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and
cisplatin IV over 1 hour on day 1 or 2. Treatment repeats every 28 days for a maximum
of 6 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive paclitaxel IV over 1 hour on days 1 and 8 followed by
cisplatin IV over 1 hour on day 1 and gemcitabine IV over 30 minutes on days 1 and 8.
Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease
progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for at least 3
years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 610 patients (305 per treatment arm) will be accrued for this
study within 3.04 years.
;
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
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