A Phase II Trial of R115777, a Farnesyl Transferase Inhibitor, in Combination With Gemcitabine and Cisplatin in Advanced Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Proportion of confirmed tumor responses, defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart
研究概览
简要总结
Phase II trial to study the effectiveness of combining tipifarnib with gemcitabine and cisplatin in treating patients who have stage III or stage IV non-small cell lung cancer. Drugs used in chemotherapy such as gemcitabine and cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Combining tipifarnib with combination chemotherapy may kill more tumor cells.
详细描述
PRIMARY OBJECTIVES:
I. To describe the response rate in non-small cell lung cancer (NSCLC) patients receiving combination therapy with R115777, gemcitabine, and cisplatin.
SECONDARY OBJECTIVES:
I. To estimate the time to event efficacy variables including: time to progressive disease, time to treatment failure, time to death of any cause.
II. To estimate the duration of response for responding patients. III. To characterize the toxicities of R115777, gemcitabine, and cisplatin in this patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Histologically confirmed NSCLC with one of the following classifications:
- •Stage IIIB with pleural effusion
- •Stage IIIB and not a candidate for combined modality treatment with radiation therapy and chemotherapy
- •Measurable disease, defined as at least one lesion whose longest diameter can be accurately measured as >= 2.0 cm
- •Absolute neutrophil count (ANC) >= 1500/mm^3
- •PLT >= 100,000
- •Hgb > 10.0 g/dL
- •Direct bilirubin =< 1.5 x UNL
- •Alkaline phosphatase =< 5 x UNL
- •AST =< 3 x UNL
- •Creatinine =< 1.5 x UNL
- •ECOG Performance Status (PS) 0 or 1
- •Capable of understanding the investigational nature, potential risks and benefits of the study and able to provide valid informed consent
排除标准
- •Any of the following as this regimen may be harmful to a developing fetus or nursing child:
- •Pregnant women
- •Breastfeeding women
- •Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.)
- •Any of the following prior therapies:
- •Prior chemotherapy for NSCLC (exception: therapies used as a radiosensitizer such as low-dose weekly cisplatin and carbo/taxol with XRT)
- •Prior radiation > 25% of bone marrow
- •Prior immunotherapy, biologic or gene therapy
- •New York Heart Association classification III or IV
- •CNS metastases
- •Uncontrolled infection
- •Any other severe, underlying diseases that are, in the judgment of the investigator, inappropriate for entry into this study
- •Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinomas, or other cancer from which the patient has been disease-free for at least five years
- •Pre-existing peripheral neuropathy (motor or sensory) > grade 1 per NCI Common Toxicity Criteria (CTC)
- •Known peripheral vascular disease or a history of deep vein thrombosis
研究组 & 干预措施
Treatment (tipifarnib, gemcitabine, cisplatin)
Patients receive oral tipifarnib twice daily on days 1-14, gemcitabine IV over 30 minutes on days 1 and 8, and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients with at least stable disease may continue to receive oral tipifarnib alone twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: tipifarnib (Drug)
Treatment (tipifarnib, gemcitabine, cisplatin)
Patients receive oral tipifarnib twice daily on days 1-14, gemcitabine IV over 30 minutes on days 1 and 8, and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients with at least stable disease may continue to receive oral tipifarnib alone twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: cisplatin (Drug)
Treatment (tipifarnib, gemcitabine, cisplatin)
Patients receive oral tipifarnib twice daily on days 1-14, gemcitabine IV over 30 minutes on days 1 and 8, and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients with at least stable disease may continue to receive oral tipifarnib alone twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: gemcitabine hydrochloride (Drug)
Treatment (tipifarnib, gemcitabine, cisplatin)
Patients receive oral tipifarnib twice daily on days 1-14, gemcitabine IV over 30 minutes on days 1 and 8, and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients with at least stable disease may continue to receive oral tipifarnib alone twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Proportion of confirmed tumor responses, defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4 weeks apart
时间窗: Up to 18 weeks (6 courses)
Ninety-five percent confidence intervals for the true success proportion will be calculated.
次要结局
- Survival time(Time from registration to death due to any cause, assessed up to 2 years)
- Time to disease progression(Time from registration to documentation of disease progression, assessed up to 2 years)
- Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented(Up to 2 years)
- Time to treatment failure(Time from the date of registration to the date at which the patient is removed from treatment due to progression, toxicity, or refusal, assessed up to 2 years)