Lung Cancer
Conditions
Keywords
extensive stage small cell lung cancer
Brief summary
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.
Detailed description
OBJECTIVES: * Determine the percentage of patients with extensive stage small cell lung cancer who live more than 12 months after treatment with carboplatin, etoposide, and exisulind. * Determine the response rate of patients treated with this regimen. * Determine the toxicity of this regimen in these patients. 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.
Interventions
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| percentage of patients with extensive stage small cell lung cancer who live more than 12 months after treatment | Up to 3 years |
Secondary
| Measure | Time frame |
|---|---|
| response rate | Up to 3 years |
Countries
Canada, Puerto Rico, United States
Outcome results
None listed