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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Study Of Gemcitabine And CPT-11 (Irinotecan) In Locally Advanced Or Metastatic Bladder Cancer

Conditions
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Bladder Cancer

Intervention / Treatment
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* Drug: gemcitabine hydrochloride
* Drug: irinotecan hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemcitabine and Irnotecan<br> | Drug: gemcitabine hydrochloride<br> <br> Drug: irinotecan hydrochloride<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Proportion |  | From registration until time of complete response or partial response | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Response |  | From registration until disease progression among patients who had at least a partial response. | 
| Frequency of Adverse Events as Assessed by NCI CTC Version 2.0 |  | From the day of first dose until the end of study, an average of 6 months | 
| Progression-free Survival |  | Time between registration and disease progression or death, whichever comes first. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transitional cell carcinoma of the bladder, recurrent bladder cancer, stage III bladder cancer, stage IV bladder cancer