Combination Chemotherapy and Exisulind in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Lung Cancer
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring extensive stage small cell lung cancer
Eligibility Criteria
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: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Abdominal masses that are not confirmed and followed by imaging techniques Cystic lesions Tumor lesions situated in a previously irradiated area Must not be considered for combined chemotherapy and radiotherapy No active CNS metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin normal AST no greater than 2 times ULN No clinically significant hepatic disease Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 60 mL/min No clinically significant renal disease Cardiovascular: No clinically significant cardiac disease Other: Not pregnant or nursing Fertile patients must use effective contraception No concurrent uncontrolled illness No known sensitivity to sulindac PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No prior chemotherapy for small cell lung cancer No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal agents except: Steroids for adrenal failure Hormones for nondisease-related conditions (e.g., insulin for diabetes) Intermittent use of dexamethasone as an antiemetic Radiotherapy: See Disease Characteristics At least 2 weeks since prior radiotherapy, including for palliation No concurrent radiotherapy Surgery: Not specified Other: More than 7 days since prior sulindac No concurrent sulindac
Sites / Locations
- Northeast Alabama Regional Medical Center
- Rebecca and John Moores UCSD Cancer Center
- Cedars-Sinai Medical Center
- Veterans Affairs Medical Center - San Diego
- UCSF Comprehensive Cancer Center
- Veterans Affairs Medical Center - San Francisco
- CCOP - Christiana Care Health Services
- Lombardi Cancer Center
- Walter Reed Army Medical Center
- Veterans Affairs Medical Center - Washington, DC
- Broward General Medical Center
- Memorial Regional Hospital Comprehensive Cancer Center
- CCOP - Mount Sinai Medical Center
- Florida Hospital Cancer Institute
- Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center
- MBCCOP - University of Illinois at Chicago
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
- University of Chicago Cancer Research Center
- Louis A. Weiss Memorial Hospital
- West Suburban Center for Cancer Care
- Saint Anthony Medical Center
- Fort Wayne Medical Oncology and Hematology, Incorporated
- CCOP - Northern Indiana CR Consortium
- Hematology Oncology Associates of the Quad Cities
- Holden Comprehensive Cancer Center
- Baptist Hospital East - Louisville
- Marlene and Stewart Greenebaum Cancer Center, University of Maryland
- Veterans Affairs Medical Center - Baltimore
- Dana-Farber Cancer Institute
- University of Massachusetts Memorial Medical Center - University Campus
- Lakeland Medical Center - St. Joseph
- Veterans Affairs Medical Center - Minneapolis
- University of Minnesota Cancer Center
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
- Ellis Fischel Cancer Center - Columbia
- Barnes-Jewish Hospital
- Siteman Cancer Center
- Missouri Baptist Cancer Center
- University of Nebraska Medical Center
- CCOP - Southern Nevada Cancer Research Foundation
- Veterans Affairs Medical Center - Las Vegas
- Norris Cotton Cancer Center
- Cooper University Hospital
- Veterans Affairs Medical Center - Buffalo
- Roswell Park Cancer Institute
- Elmhurst Hospital Center
- Queens Cancer Center of Queens Hospital
- CCOP - North Shore University Hospital
- North Shore University Hospital
- Memorial Sloan-Kettering Cancer Center
- Weill Medical College of Cornell University
- Mount Sinai Medical Center, NY
- State University of New York - Upstate Medical University
- Veterans Affairs Medical Center - Syracuse
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
- Veterans Affairs Medical Center - Asheville
- Lineberger Comprehensive Cancer Center, UNC
- NorthEast Oncology Associates
- Veterans Affairs Medical Center - Durham
- Duke Comprehensive Cancer Center
- Cape Fear Valley Health System
- Lenoir Memorial Hospital Cancer Center
- FirstHealth Moore Regional Hospital
- New Hanover Regional Medical Center
- CCOP - Southeast Cancer Control Consortium
- Comprehensive Cancer Center at Wake Forest University
- Veterans Affairs Medical Center - Fargo
- Arthur G. James Cancer Hospital - Ohio State University
- Western Pennsylvania Hospital
- Lifespan: The Miriam Hospital
- Veterans Affairs Medical Center - Dallas
- Simmons Cancer Center - Dallas
- Green Mountain Oncology Group
- Vermont Cancer Center
- Veterans Affairs Medical Center - White River Junction
- Martha Jefferson Hospital
- Virginia Oncology Associates - Norfolk
- MBCCOP - Massey Cancer Center
- Oncology and Hematology Associates of Southwest Virginia, Inc.
- St. Mary's Medical Center
- Ministry Medical Group - Northern Region
- McGill University
- University of Puerto Rico School of Medicine Medical Sciences Campus
Arms of the Study
Arm 1
Experimental
carboplatin + etoposide + exisulind
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.