Pemetrexed Disodium and Gemcitabine in Treating Patients With Advanced Cancer of the Urothelium
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|ClinicalTrials.gov Identifier: NCT00053209|
Recruitment Status : Completed
First Posted : January 28, 2003
Last Update Posted : December 4, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer||Drug: gemcitabine hydrochloride Drug: pemetrexed disodium||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial Of Pemetrexed Disodium And Gemcitabine In Advanced Urothelial Cancer|
|Study Start Date :||April 2004|
|Actual Primary Completion Date :||September 2007|
|Actual Study Completion Date :||May 2009|
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
- Response as measured by RECIST criteria [ Time Frame: Assessed every 6 weeks ]
- Time to disease progression [ Time Frame: Assessed every 6 weeks ]
- Overall survival [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00053209
|Study Chair:||Robert Dreicer, MD, FACP||The Cleveland Clinic|