• Response rate [ Designated as safety issue: No ]
  
• Overall survival [ Designated as safety issue: No ]
  
• Progression-free survival [ Designated as safety issue: No ]
  
• Toxicity [ Designated as safety issue: Yes ]
  

OBJECTIVES:

• Determine the response rate of patients with locally recurrent or metastatic unresectable renal cell cancer with sarcomatoid features treated with doxorubicin and gemcitabine.
• Determine the progression-free and overall survival of patients treated with this regimen.
• Determine the toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive doxorubicin IV and gemcitabine IV over 30 minutes on day 1. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 2- or 3-10 or pegfilgrastim SC on day 2. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

After 6 courses, patients undergo a MUGA scan. Patients with a stable* left ventricular ejection fraction (LVEF) continue therapy as above. Patients who reach a total doxorubicin dose of 450 mg/m^2 and are found to have unstable cardiac function or who have an abnormal LVEF continue therapy with gemcitabine alone.

NOTE: *Stable cardiac function is defined as no decrease more than 15% of LVEF in absolute number and LVEF at least 35% in total function by MUGA.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 16-40 patients will be accrued for this study within 1.3-3.3 years.

DISEASE CHARACTERISTICS:

• Histologically confirmed renal cell carcinoma

  • Features must be of sarcomatoid histology
  • Locally recurrent or metastatic disease not amenable to resection
• Measurable disease
• Original diagnostic material available for pathology review
• No prior or concurrent brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• 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

Hepatic

• Bilirubin less than 1.5 mg/dL
• AST less than 2 times upper limit of normal

Renal

• Creatinine no greater than 2.0 mg/dL

Cardiovascular

• No myocardial infarction within the past year
• No congestive heart failure within the past year
• No significant ischemic or valvular heart disease within the past year
• LVEF at least lower limit of normal by MUGA

Other

• Not pregnant or nursing
• 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
• No active infection that would preclude study treatment
• No other concurrent serious medical illness that would preclude study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• At least 4 weeks since prior radiotherapy and recovered

  • No previously irradiated lesions as the sole site of disease
• No concurrent local radiotherapy for pain control or for life-threatening situations

Surgery

• Prior nephrectomy allowed
• Recovered from prior surgery

Other

• No prior treatment for advanced disease