Phase II Trial Of Pemetrexed Disodium And Gemcitabine In Advanced Urothelial Cancer
Phase II Trial Of Pemetrexed Disodium And Gemcitabine In Advanced Urothelial Cancer
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.
OBJECTIVES:
Primary
Secondary
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.
DISEASE CHARACTERISTICS:
Histologically confirmed cancer of the urothelium (renal pelvis, ureter, bladder, or urethra)
Any of the following types:
Progressing regional or metastatic disease
Measurable disease
No clinical evidence of CNS metastases
No evidence of clinically significant (by physical exam or plain film) third-space fluid collections (pleural effusions or ascites)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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