R115777 in Treating Patients With Recurrent or Metastatic Non-small Cell Lung Cancer

Mayo Clinic

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Lung Cancer

Interventions

tipifarnibDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Mayo Clinic in Florida

Jacksonville, Florida, United States

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Mayo Clinic

Rochester, Minnesota, United States

Data from ClinicalTrials.gov

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