Pemetrexed Disodium and Gemcitabine in Treating Patients With Advanced Cancer of the Urothelium
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.
Transitional Cell Cancer of the Renal Pelvis and Ureter
Drug: gemcitabine hydrochloride
Drug: pemetrexed disodium
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial Of Pemetrexed Disodium And Gemcitabine In Advanced Urothelial Cancer|
- Response as measured by RECIST criteria [ Time Frame: Assessed every 6 weeks ] [ Designated as safety issue: No ]
- Time to disease progression [ Time Frame: Assessed every 6 weeks ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||April 2004|
|Study Completion Date:||May 2009|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
Experimental: Pemetrexed Disodium and Gemcitabine
Pemetrexed disodium 500 mg/m2 followed by gemcitabine 1000 mg/m2 on day 1 and gemcitabine 1000 mg/m2 on day 8 of a 21-day cycle for a maximum of 6 cycles
|Drug: gemcitabine hydrochloride Drug: pemetrexed disodium|
- 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.
- 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.