Status:
COMPLETED
Gemcitabine and Irinotecan in Treating Patients With Metastatic Kidney Cancer
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Kidney Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief 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. Givi...
Detailed Description
OBJECTIVES: * Determine the response rate in patients with epithelial (clear or nonclear cell) renal cell carcinoma (RCC) treated with gemcitabine hydrochloride and irinotecan hydrochloride. * Compar...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00401128
Start Date
May 1 2004
End Date
February 1 2007
Last Update
April 20 2017
Active Locations (1)
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1
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065