Gemcitabine and Irinotecan in Treating Patients With Locally Advanced or Metastatic Bladder Cancer

OBJECTIVES:

Primary

- Determine response in patients with locally advanced or metastatic transitional cell
carcinoma of the bladder treated with gemcitabine and irinotecan.

Secondary

- Determine the duration of response in patients treated with this regimen.

- Determine the tolerance to and toxicity of this regimen in these patients.

- Determine the median and progression-free survival of patients treated with this
regimen.

OUTLINE: Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on
days 1 and 8. Courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity. Patients with responding disease receive 2 additional courses beyond
best response.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 24 months.

DISEASE CHARACTERISTICS:

- Histologically confirmed transitional cell carcinoma of the bladder

- Locally advanced or metastatic disease

- Unidimensionally measurable disease by physical exam or imaging study

- The following are not considered measurable disease:

- Bone only disease

- Pleural or peritoneal effusions

- CNS lesions

- Irradiated lesions unless disease progression was documented after
radiotherapy

- Not amenable to surgery

PATIENT CHARACTERISTICS:

Age

- Over 18

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

Hepatic

- Bilirubin ≤ 2.0 mg/dL

Renal

- Creatinine ≤ 2.0 mg/dL

Gastrointestinal

- No active inflammatory bowel disease

- No significant bowel obstruction

- No chronic diarrhea

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other active malignancy except nonmelanoma skin cancer

- No mental incapacitation or psychiatric illness that would preclude giving informed
consent

- No other severe disease that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)

Chemotherapy

- No more than 1 prior platinum-based chemotherapy regimen

- At least 4 weeks since prior chemotherapy

- No prior irinotecan or gemcitabine

- No other concurrent chemotherapy

Endocrine therapy

- No concurrent hormones except steroids for adrenal failure, hormones for
non-disease-related conditions (e.g., insulin for diabetes), and intermittent
dexamethasone as an antiemetic

Radiotherapy

- See Disease Characteristics

- At least 4 weeks since prior radiotherapy

- No concurrent palliative radiotherapy

Surgery

- Not specified

Other

- No concurrent participation in another clinical trial