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Pemetrexed Disodium and Gemcitabine in Treating Patients With Advanced Cancer of the Urothelium

Bladder Cancer Clinical Trial

Official title:
Phase II Trial Of Pemetrexed Disodium And Gemcitabine In Advanced Urothelial Cancer

Clinical Trial Summary

RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining pemetrexed disodium with gemcitabine may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining pemetrexed disodium with gemcitabine in treating patients who have advanced cancer of the urothelium.

Clinical Trial Description

OBJECTIVES: Primary - Determine the response rate in patients with previously untreated advanced cancer of the urothelium treated with pemetrexed disodium and gemcitabine. - Determine the toxicity of this regimen in these patients. Secondary - Determine the overall survival and time to progression in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive pemetrexed disodium IV over 10 minutes on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Patients also receive cyanocobalamin intramuscularly once every 9 weeks and folic acid orally once daily beginning on day -6 and continuing until 3 weeks after the completion of study therapy. Treatment repeats every 3 weeks for up to 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 3 years. PROJECTED ACCRUAL: A total of 24-46 patients will be accrued for this study within 15 -18 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00053209
Study type Interventional
Source Eastern Cooperative Oncology Group
Contact
Status Completed
Phase Phase 2
Start date August 10, 2004
Completion date May 2009
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