Gemcitabine and Irinotecan in Treating Patients With Metastatic Kidney Cancer

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Camptothecin; Gemcitabine; Irinotecan

Criteria

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