Two-Drug Combination Chemotherapy Compared With Four-Drug Combination Chemotherapy in Treating Patients With Advanced Cancer of the Urothelium
Condition: Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter; Urethral Cancer
MeSH terms: Urinary Bladder Neoplasms; Urethral Neoplasms; Carcinoma, Transitional Cell; Kidney Neoplasms; Ureteral Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      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 if four-drug combination chemotherapy is more effective than two-drug combination
      chemotherapy in treating advanced cancer of the urothelium.

      PURPOSE: Randomized phase III trial to compare the effectiveness of four-drug combination
      chemotherapy with that of two-drug combination chemotherapy in treating patients who have
      advanced cancer of the urothelium.
    

Detailed description: 
      OBJECTIVES: I. Compare the objective response rate, duration of remission, overall survival,
      and quality of life of patients with progressing regional or metastatic transitional cell
      carcinoma (or mixed histologies with a component of transitional cell carcinoma) of the
      urothelium treated with methotrexate, vinblastine, doxorubicin, and cisplatin vs carboplatin
      and paclitaxel. II. Compare the relative toxic effects of these treatment regimens in this
      patient population.

      OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment
      arms. Arm I: Patients receive methotrexate IV on days 1, 15, and 22; vinblastine IV on days
      2, 15, and 22; and cisplatin IV over 2 hours and doxorubicin IV on day 2. Treatment repeats
      every 28 days for a total of 6 courses in the absence of unacceptable toxicity or disease
      progression. Arm II: Patients receive paclitaxel IV over 3 hours immediately followed by
      carboplatin IV over 30 minutes. Treatment repeats every 21 days for a total of 6 courses in
      the absence of unacceptable toxicity or disease progression. Quality of life is assessed
      before treatment, before courses 2 and 4, at 4 weeks after last course, and at 10 months.
      Patients are followed every 3 months for 1 year and then every 6 months until disease
      progression.

      PROJECTED ACCRUAL: A total of 330 patients will be accrued for this study within 3.3 years.
    

Intervention name(s): carboplatin; cisplatin; doxorubicin hydrochloride; methotrexate; paclitaxel; vinblastine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Paclitaxel; Vinblastine; Carboplatin; Doxorubicin; Liposomal doxorubicin; Methotrexate
Allocation: Randomized
Primary purpose: Treatment
Keywords: stage III bladder cancer; stage IV bladder cancer; transitional cell carcinoma of the bladder; anterior urethral cancer; posterior urethral cancer; urethral cancer associated with invasive bladder cancer; metastatic transitional cell cancer of the renal pelvis and ureter; regional transitional cell cancer of the renal pelvis and ureter