Phase
Condition
Kidney Cancer
Renal Cell Carcinoma
Urothelial Tract Cancer
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
DISEASE CHARACTERISTICS:
Histologically proven previously untreated metastatic or unresectable renal cell carcinoma
Retroperitoneal lymph nodes that are unresectable or those that are not resected at the investigator's discretion are considered metastatic disease
Prior nephrectomy allowed provided there is evidence of unresponsive metastatic disease after surgery or within one month prior to study enrollment
Bidimensionally measurable disease
Measurable disease must be outside any prior radiotherapy port
No history of brain metastases unless surgically resected or treated with gamma knife radiotherapy and currently without radiologic evidence of CNS disease
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
Absolute neutrophil count at least 1,500/mm^3
Hemoglobin at least 9 g/dL (transfusion allowed)
Platelet count at least 100,000/mm^3
Hepatic:
Bilirubin no greater than 1.5 mg/dL
SGOT no greater than 3 times upper limit of normal
Renal:
Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance at least 60 mL/min
Cardiovascular:
- No myocardial infarction within the past 6 months
Other:
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use 2 effective methods of contraception (1 highly active method and 1 barrier method) for at least 4 weeks before, during, and for at least 4 weeks after study participation
No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
No uncontrolled diabetes or any other concurrent illnesses that would increase risk
No history of peripheral neuropathy
No severe depression
PRIOR CONCURRENT THERAPY:
Biologic therapy:
No prior immunotherapy (including adjuvant interferon alfa therapy), cellular therapy, or vaccine therapy for renal cell carcinoma
No prior antiangiogenesis therapy for renal cell carcinoma
Immunotherapy for prior malignancy allowed (except for interferon alfa therapy)
Chemotherapy:
No prior chemotherapy for renal cell carcinoma
Chemotherapy for prior malignancy allowed
Endocrine therapy:
- No prior hormonal therapy for renal cell carcinoma
Radiotherapy:
See Disease Characteristics
At least 2 weeks since prior radiotherapy and recovered
Surgery:
- See Disease Characteristics
Other:
- More than 7 days since prior IV antibiotics for infection
Study Design
Study Description
Connect with a study center
Westmead Hospital
Westmead, New South Wales 2145
AustraliaSite Not Available
Instituto de Enfermedades Neoplasicas
Lima, 34
PeruSite Not Available
San Juan City Hospital
San Juan, 00936-7344
Puerto RicoSite Not Available
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona 85259-5404
United StatesSite Not Available
CCOP - Northern Indiana CR Consortium
South Bend, Indiana 46601
United StatesSite Not Available
Iowa Lutheran Hospital
Des Moines, Iowa 50316-2301
United StatesSite Not Available
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa 50309
United StatesSite Not Available
Mercy Cancer Center at Mercy Medical Center-Des Moines
Des Moines, Iowa 50314
United StatesSite Not Available
Midlands Cancer Center at Midlands Community Hospital
Papillion, Nebraska 68128-4157
United StatesSite Not Available
Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
United StatesSite Not Available
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico 87131
United StatesSite Not Available
Comprehensive Cancer Center at Our Lady of Mercy Medical Center
Bronx, New York 10466
United StatesSite Not Available
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033-0850
United StatesSite Not Available
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin 54307-3453
United StatesSite Not Available
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