Bladder Cancer Clinical Trial
Gemcitabine and Irinotecan in Treating Patients With Locally Advanced or Metastatic Bladder Cancer
Summary
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.
Full Description
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.
Eligibility 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
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There is 1 Location for this study
Charleston South Carolina, 29425, United States
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