Phase II Trial of Doxorubicin and Gemcitabine in Metastatic Renal Cell Carcinoma With Sarcomatoid Features

Inclusion Criteria

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