NCT00014274

Combination Chemotherapy in Treating Patients With Transitional Cell Cancer of the Urothelium

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 238 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 which combination chemotherapy regimen is most effective for transitional cell cancer of the urothelium. PURPOSE: Randomized phase II/III trial to compare different combination chemotherapy regimens in treating patients who have transitional cell cancer of the urothelium.

Detailed description

OBJECTIVES: * 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 treatment arms. * 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 thereafter. 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.

Conditions

• Bladder Cancer
• Transitional Cell Cancer of the Renal Pelvis and Ureter
• Urethral Cancer

Interventions

Type	Name	Description
DRUG	carboplatin
DRUG	gemcitabine hydrochloride
DRUG	methotrexate
DRUG	vinblastine sulfate

Timeline

• Start date: 2001-01-01
• Primary completion: 2008-03-01
• First posted: 2003-01-27
• Last updated: 2013-06-12

Locations

29 sites across 11 countries: Austria, Belgium, Denmark, Germany, Hungary, Israel, Italy, Netherlands, Poland, Spain, United Kingdom