RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with irinotecan works in treating patients with locally advanced or metastatic bladder cancer.

Condition	Treatment or Intervention	Phase
transitional cell carcinoma of the bladder recurrent bladder cancer stage III bladder cancer stage IV bladder cancer	Drug: gemcitabine  Drug: irinotecan  Procedure: chemotherapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

South Carolina
      Hollings Cancer Center at Medical University of South Carolina, Charleston,  South Carolina,  29425-2225,  United States; Recruiting

Study chairs or principal investigators

Uzair B. Chaudhary, MD,  Study Chair,  Medical University of South Carolina   

Study ID Numbers:  CDR0000378047; MUSC-100615; PHARMACIA-440EONCO020298; MUSC-HR-10212; NCT00089128
Record last reviewed:  July 2004
Last Updated:  February 15, 2005
Record first received:  August 4, 2004
ClinicalTrials.gov Identifier:  NCT00089128
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08