Gemcitabine and Irinotecan in Treating Patients With Locally Advanced Unresectable or Metastatic Kidney 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 unresectable or metastatic kidney cancer.

Detailed Description
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OBJECTIVES: Primary Determine response in patients with locally advanced unresectable or metastatic renal cell carcinoma 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 median and progression-free survival in patients treated with this regimen. OUTLINE: Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for 6-8 courses in the absence of disease progression or unacceptable toxicity. Patients 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 12-36 patients will be accrued for this study within 30 months.

Official Title
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Phase II Study of Gemcitabine and CPT-11 (Irinotecan) in Unresectable or Metastatic Renal Cell Carcinoma

Conditions
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Kidney 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 renal cell carcinoma Locally advanced unresectable 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 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 ALT and AST < 3 times upper limit of normal 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 during and for 6 months after study participation No mental incapacitation or psychiatric illness that would preclude giving informed consent No other active malignancy except nonmelanoma skin cancer No other severe disease that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy At least 4 weeks since prior immunotherapy No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF) Chemotherapy No prior chemotherapy 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), or 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 + Irinotecan<br> | Drug: gemcitabine hydrochloride<br>* 1,000 mg/m2/dose in 250 cc of NS IV over 30 minutes on Days 1 and 8 of each 21 day cycle<br>Drug: irinotecan hydrochloride<br>* 100mg/m2/dose in 500 cc of D5W or NS IV over 90 minutes on days 1 and 8 of each 21 day cycle<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 | 
| Number of Participants Who Experienced SAEs on Study |  | From the day of first dose until the end of study, for 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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recurrent renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer