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

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