Doxorubicin and Gemcitabine in Treating Patients With Locally Recurrent or Metastatic Unresectable Renal Cell Carcinoma

INCLUSION CRITERIA:

Histologically confirmed renal cell carcinoma

Features must be of sarcomatoid histology
Locally recurrent or metastatic disease not amenable to resection
Measurable disease
Must have a prior nephrectomy provided all other eligibility criteria are met, and adequately recovered from any recent surgery
At least 4 weeks since prior radiotherapy and recovered
ECOG performance status of 0-1
WBC greater than 3,000/mm^3 or absolute neutrophil count greater than 1,500/mm^3
Platelet count greater than 100,000/mm^3
Bilirubin less than 1.5 mg/dL
Aspartate aminotransferase (AST) less than 2 times upper limit of normal
Creatinine no greater than 2.0 mg/dL
LVEF at least lower limit of normal by MUGA
Negative pregnancy test
Fertile patients must use effective contraception
Other prior malignancy allowed provided patient was curatively treated and has been disease free from that cancer
Age of 18 and over
Diagnostic material from the kidney or metastatic site biopsy available for central pathologic review

EXCLUSION CRITERIA:

Prior treatment for advanced disease
Previously irradiated lesions as the sole site of disease for patients with prior radiation therapy
Concurrent local radiotherapy for pain control or for life-threatening situations
Myocardial infarction within the past year
Congestive heart failure within the past year
Significant ischemic or valvular heart disease within the past year
Prior or concurrent brain metastases
Concurrent serious medical illness that would preclude study treatment
Active infection that would preclude study treatment
Pregnant or nursing