Lung Cancer
Conditions
Keywords
limited stage small cell lung cancer, extensive stage small cell lung cancer, recurrent small cell lung cancer
Brief summary
Phase II trial to study the effectiveness of fenretinide in treating patients who have recurrent small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Detailed description
OBJECTIVES: I. Determine the efficacy of fenretinide, in terms of complete and partial response rates, duration of response, and survival, in patients with recurrent small cell lung cancer. II. Determine the toxicity of this regimen in these patients. III. Correlate the induction of apoptosis or the expression of molecular mediators of apoptosis in tumor cells with response rates, response duration, and survival in patients treated with this regimen. OUTLINE: This is an open-label, multicenter study. Patients receive oral fenretinide twice daily on days 1-7. Treatment continues every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 1 month.
Interventions
DRUGfenretinide
Sponsors
National Cancer Institute (NCI)
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 recurrent small cell lung cancer (SCLC) after platinum-containing chemotherapy regimen with or without thoracic radiotherapy * Limited stage or extensive stage SCLC * Measurable disease * At least 20 mm by conventional techniques OR * At least 10 mm with spiral CT scan * No pleural effusions, bone metastases, brain metastases, or abnormal radionucleotide scans as sole evidence of disease * No symptomatic or uncontrolled brain or leptomeningeal disease * Previously treated brain metastases allowed if neurologically stable PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Zubrod 0-2 Hematopoietic: * WBC at least 2,500/mm\^3 * Platelet count at least 70,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 mg/dL * SGOT no greater than 2 times upper limit of normal Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance at least 60 mL/min Cardiovascular: * No symptomatic heart disease * No myocardial infarction within the past 6 months Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception for 1 month before, during, and for 2 months after study * No pre-existing retinal degenerative disease (e.g., retinitis pigmentosa or associated disorders) * No other serious concurrent illness * No other malignancy within the past 5 years except localized nonmelanoma skin cancer or carcinoma in situ PRIOR CONCURRENT THERAPY: Chemotherapy: * At least 3 weeks since prior chemotherapy * No more than 2 prior chemotherapy regimens Endocrine therapy: * Concurrent steroids allowed at stable dose Radiotherapy: * No prior radiotherapy to study lesions Other: * At least 3 weeks since prior systemic retinoid or carotenoid therapy * No concurrent anticonvulsants
Countries
United States
Outcome results
None listed