Phase II Trial of Doxorubicin and Gemcitabine in Metastatic Renal Cell Carcinoma With Sarcomatoid Features
Phase II Trial of Doxorubicin and Gemcitabine in Metastatic Renal Cell Carcinoma With Sarcomatoid Features
RATIONALE: Drugs used in chemotherapy, such as doxorubicin and gemcitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving doxorubicin together with gemcitabine works in treating patients with locally recurrent or metastatic unresectable renal cell carcinoma (kidney cancer).
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive doxorubicin intravenously (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.
ACTUAL ACCRUAL: A total of 39 patients were accrued for this study.
INCLUSION CRITERIA:
Histologically confirmed renal cell carcinoma
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:
Los Angeles, California 90089-9181, United States
Aurora, Colorado 80045, United States
Chicago, Illinois 60611-3013, United States
Libertyville, Illinois 60048, United States
Skokie, Illinois 60076, United States
La Porte, Indiana 46350, United States
Dearborn, Michigan 48123-2500, United States
Grosse Pointe Woods, Michigan 48236, United States
Saint Joseph, Michigan 49085, United States
Billings, Montana 59101, United States
Missoula, Montana 59807, United States
Flemington, New Jersey 08822, United States
New Brunswick, New Jersey 08903, United States
The Bronx, New York 10466, United States
Hershey, Pennsylvania 17033-0850, United States
Lemoyne, Pennsylvania 17043, United States
Sioux Falls, South Dakota 57117-5039, United States
Parkersburg, West Virginia 26102, United States
La Crosse, Wisconsin 54601, United States
Madison, Wisconsin 53792-6164, United States