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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Study of Farnesyl Transferase Inhibitor R115777 in Patients With Advanced Non-Small Cell Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: tipifarnib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: tipifarnib|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent non-small cell lung cancer, stage IV non-small cell lung cancer