Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer
Conditions
Keywords
metastatic transitional cell cancer of the renal pelvis and ureter, recurrent transitional cell cancer of the renal pelvis and ureter, regional transitional cell cancer of the renal pelvis and ureter, transitional cell carcinoma of the bladder, recurrent bladder cancer, stage III bladder cancer, stage IV bladder cancer, anterior urethral cancer, posterior urethral cancer, recurrent urethral cancer, urethral cancer associated with invasive bladder cancer
Brief 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.
Detailed 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.
Interventions
DRUGgemcitabine hydrochloride
DRUGpemetrexed disodium
Sponsors
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed cancer of the urothelium (renal pelvis, ureter, bladder, or urethra) * Any of the following types: * Transitional cell carcinoma (TCC) * Mixed histologies containing a component of TCC * Non-TCC of the urothelium (renal pelvis, ureter, bladder, or urethra) * 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 * 18 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9 g/dL Hepatic * AST no greater than 3 times upper limit of normal (ULN) * Bilirubin no greater than 1.5 times ULN Renal * Creatinine clearance at least 45 mL/min Cardiovascular * No history of severe cardiovascular disease (i.e., American Heart Association class III or IV heart disease) * No uncontrolled congestive heart failure * No ventricular dysrhythmias Other * Not pregnant or nursing * Fertile patients must use effective contraception * No active unresolved infection * No other prior malignancy unless curatively treated and disease free for an appropriate (disease-specific) period of time * Able and willing to receive folic acid and cyanocobalamin supplementation PRIOR CONCURRENT THERAPY: Biologic therapy * No prior systemic biologic response modifier therapy Chemotherapy * No prior systemic chemotherapy for metastatic disease * More than 1 year since prior neoadjuvant or adjuvant chemotherapy Endocrine therapy * Not specified Radiotherapy * At least 4 weeks since prior radiotherapy and recovered * No prior pelvic radiotherapy * No concurrent radiotherapy Surgery * At least 4 weeks since prior major surgery and recovered Other * More than 7 days since prior parenteral antibiotics * No salicylates for 2 days before, during, and for 2 days after administration of pemetrexed disodium * No nonsteroidal anti-inflammatory drugs for at least 5 days before, during, and for 2 days after administration of pemetrexed disodium
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response as measured by RECIST criteria | Assessed every 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Time to disease progression | Assessed every 6 weeks |
| Overall survival | Assessed every 3 months for 2 years, then every 6 months for 3 years |
Countries
United States
Outcome results
None listed