A Phase II Study of Carboplatin, Etoposide, and Exisulind in Patients With Extensive Small Cell Lung Cancer
A Phase II Study of Carboplatin, Etoposide, and Exisulind in Patients With Extensive Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Exisulind may make tumor cells more sensitive to chemotherapy. Combining chemotherapy with exisulind may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with exisulind in treating patients who have extensive-stage small cell lung cancer.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive carboplatin IV over 30 minutes on day 1 and etoposide IV over 30-60 minutes on days 1-3. Patients also receive oral exisulind twice daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 2 months for 1 year and then every 4 months for 2 years.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed small cell lung cancer
At least 1 unidimensionally measurable lesion
At least 20 mm by conventional techniques OR
At least 10 mm by spiral CT scan
Lesions considered nonmeasurable include:
Must not be considered for combined chemotherapy and radiotherapy
No active CNS metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
No concurrent hormonal agents except:
Radiotherapy:
Surgery:
Other:
Washington D.C., District of Columbia 20422, United States
West Palm Beach, Florida 33401, United States
Fort Wayne, Indiana 46885-5099, United States
Baltimore, Maryland 21201, United States
Worcester, Massachusetts 01655, United States
Syracuse, New York 13217, United States
Winston-Salem, North Carolina 27157-1082, United States
White River Junction, Vermont 05009, United States
Roanoke, Virginia 24014, United States