Lung Cancer
Conditions
Keywords
recurrent non-small cell lung cancer, stage IV non-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. PURPOSE: Phase II trial to study the effectiveness of R115777 in treating patients who have recurrent or metastatic non-small cell lung cancer.
Detailed description
OBJECTIVES: * Assess the response rate of patients with recurrent or metastatic non-small cell lung cancer when treated with tipifarnib. * Determine the clinical toxicities of this treatment in these patients. * Assess the overall survival and time to progression of this patient population when treated with this regimen. * Evaluate the inhibition of protein farnesylation in vivo and correlate such inhibition to plasma levels of tipifarnib. * Evaluate the occurrence of CYP450 polymorphisms and relate these to drug toxicity, pharmacokinetics, and response to this treatment in this patient population. OUTLINE: This is a multicenter study. Patients receive oral tipifarnib twice daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 5 years. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study over 12 months.
Interventions
DRUGtipifarnib
Sponsors
National Cancer Institute (NCI)
Mayo Clinic
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed recurrent or metastatic non-small cell lung cancer (NSCLC) * Measurable disease * At least 20 mm in at least one dimension * Nonmeasurable is defined as any of the following: * Bone lesions * Leptomeningeal disease * Ascites * Pleural/pericardial effusion * Inflammatory breast disease * Lymphangitis cutis/pulmonis * Abdominal masses not confirmed and followed by imaging techniques * Cystic lesions * No CNS metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 12 weeks Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than 2 times upper limit of normal (ULN) * AST no greater than 3 times ULN (no greater than 5 times ULN in case of hepatic metastases) Renal * Creatinine no greater than 2 times ULN Cardiovascular * No New York Heart Association class III or IV heart disease Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No uncontrolled infection * No other prior malignancy in past 5 years except adequately treated basal cell or squamous cell skin cancer or other adequately treated noninvasive carcinomas * No other concurrent severe underlying disease PRIOR CONCURRENT THERAPY: Biologic therapy * No prior biologic, gene, or immunotherapy Chemotherapy * No prior chemotherapy for NSCLC except low dose cisplatin as radiosensitizer Endocrine therapy * Not specified Radiotherapy * Prior radiotherapy to less than 25% of bone marrow allowed Surgery * Not specified
Countries
United States
Outcome results
None listed