NCT00005989已完成2 期
A Phase II Study of Farnesyl Transferase Inhibitor R115777 in Patients With Advanced Non-Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 试验地点
- 5
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 12 weeks
- •Hematopoietic
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •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)
- •Creatinine no greater than 2 times ULN
- •Cardiovascular
- •No New York Heart Association class III or IV heart disease
- •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
- •Not specified
排除标准
- 未提供
研究者
研究点 (5)
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