Gemcitabine and Irinotecan in Treating Patients With 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 the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving gemcitabine together with irinotecan works in treating patients with metastatic kidney cancer.

Detailed Description
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OBJECTIVES: Determine the response rate in patients with epithelial (clear or nonclear cell) renal cell carcinoma (RCC) treated with gemcitabine hydrochloride and irinotecan hydrochloride. Compare the response in patients with clear cell RCC vs nonclear cell RCC treated with this regimen. Determine the toxicities of this regimen. OUTLINE: This is an open-label study. Patients receive gemcitabine hydrochloride IV over 30 minutes and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for at least 6 courses in the absence of unacceptable toxicity or disease progression. After completion of study treatment, patients are followed every 3 months for 1 year. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Official Title
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Phase II Study of Gemcitabine Plus Irinotecan in Patients With 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 or cytologically confirmed epithelial renal cell carcinoma (RCC), including either clear cell or nonclear cell RCC Strong clinical evidence or biopsy proof of metastases to a site or sites distant from the primary tumor Measurable disease No untreated or progressive CNS metastases PATIENT CHARACTERISTICS: ECOG performance status 0-1 Life expectancy > 3 months Absolute neutrophil count > 1,500/mm³ Platelet count > 100,000/mm³ Hemoglobin > 9.5 g/dL Creatinine ≤ 1.8 mg/dL Bilirubin < 1.5 mg/dL Calcium < 11.5 mg/dL ALT and AST < 3 times upper limit of normal No history of any of the following: Serious cardiac arrhythmia or cardiac arrhythmia requiring treatment Congestive heart failure Angina pectoris Other severe cardiovascular disease producing limitations of physical activity (i.e., New York Heart Association class III-IV heart disease) No other prior malignancy except for the following: Basal cell or squamous cell carcinoma of the skin Carcinoma in situ of the uterine cervix Any malignancy treated with curative intent and in complete remission for > 3 years No active peptic ulcer disease, inflammatory bowel disease, or chronic diarrhea No local or systemic infections requiring IV antibiotics within the past 28 days Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Recovered from prior hormonal therapy, radiotherapy, biologic therapy, or chemotherapy No more than 3 prior therapeutic regimens for metastatic disease No prior organ allograft More than 28 days since prior major surgery requiring general anesthesia More than 28 days since prior radiotherapy to control pain from skeletal lesions More than 28 days since prior hormonal treatment

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

| Intervention/Treatment |
| --- |
|Drug: gemcitabine hydrochloride|nan|
|Drug: irinotecan hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response |  |  | 
| Safety and efficacy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in response to therapy in patients with clear vs nonclear cell renal cell carcinoma |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clear cell renal cell carcinoma, recurrent renal cell cancer, papillary renal cell carcinoma, stage IV renal cell cancer