A Phase I Study Of Genasense, A Bcl-2 Antisense Oligonucleotide, Combined With Carboplatin And Etoposide In Patients With Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Feasibility and toxicity of the regimen monitored using the Common Toxicity Criteria Version 2.0
研究概览
简要总结
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may make tumor cells more sensitive to chemotherapy drugs. Phase I trial to study the effectiveness of combination chemotherapy and oblimersen in treating patients who have extensive-stage small cell lung cancer
详细描述
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose of oblimersen when combined with standard dose carboplatin and etoposide in patients with previously untreated extensive stage small cell lung cancer.
II. Determine the toxicity and feasibility of this regimen in these patients. III. Determine potential antitumor activity of this regimen as assessed by objective response in these patients.
OUTLINE: This is a multicenter, dose-escalation study of oblimersen (G3139).
Patients receive G3139 IV continuously on days 1-8, carboplatin IV over 30 minutes on day 6, and etoposide IV over 1 hour on days 6-8. Treatment repeats every 3 weeks for up to 6 courses in the absence of unacceptable toxicity or disease progression.
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 or cytologically confirmed extensive stage small cell lungcancer
- •No active CNS disease
- •CNS metastasis allowed provided patient completed 1 course of CNS radiotherapy
- •Performance status - ECOG 0-2
- •Performance status - Karnofsky 60-100%
- •More than 2 months
- •WBC at least 3,000/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin normal
- •AST and ALT no greater than 2.5 times upper limit of normal (ULN)
- •PT and PTT no greater than 1.5 times ULN
- •Creatinine normal
- •Creatinine clearance at least 60 mL/min
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No prior allergic reactions to compounds of similar chemical or biologic composition to study agents
- •No other uncontrolled concurrent illness
- •No ongoing or active infection
- •No psychiatric illness or social situation that would preclude study compliance
- •See Disease Characteristics
- •At least 1 week since prior CNS radiotherapy and recovered
- •No prior radiotherapy to more than 25% of skeleton
- •No other prior anticancer therapy
- •No other concurrent investigational agents
- •No other concurrent anticancer therapy
- •No concurrent anticoagulation therapy
- •No concurrent combination antiretroviral therapy for HIV-positive patients
排除标准
- 未提供
研究组 & 干预措施
Treatment (oblimersen sodium, carboplatin, etoposide)
Patients receive G3139 IV continuously on days 1-8, carboplatin IV over 30 minutes on day 6, and etoposide IV over 1 hour on days 6-8. Treatment repeats every 3 weeks for up to 6 courses in the absence of unacceptable toxicity or disease progression.
干预措施: oblimersen sodium (Biological)
Treatment (oblimersen sodium, carboplatin, etoposide)
Patients receive G3139 IV continuously on days 1-8, carboplatin IV over 30 minutes on day 6, and etoposide IV over 1 hour on days 6-8. Treatment repeats every 3 weeks for up to 6 courses in the absence of unacceptable toxicity or disease progression.
干预措施: carboplatin (Drug)
Treatment (oblimersen sodium, carboplatin, etoposide)
Patients receive G3139 IV continuously on days 1-8, carboplatin IV over 30 minutes on day 6, and etoposide IV over 1 hour on days 6-8. Treatment repeats every 3 weeks for up to 6 courses in the absence of unacceptable toxicity or disease progression.
干预措施: etoposide (Drug)
Treatment (oblimersen sodium, carboplatin, etoposide)
Patients receive G3139 IV continuously on days 1-8, carboplatin IV over 30 minutes on day 6, and etoposide IV over 1 hour on days 6-8. Treatment repeats every 3 weeks for up to 6 courses in the absence of unacceptable toxicity or disease progression.
干预措施: pharmacological study (Other)
Treatment (oblimersen sodium, carboplatin, etoposide)
Patients receive G3139 IV continuously on days 1-8, carboplatin IV over 30 minutes on day 6, and etoposide IV over 1 hour on days 6-8. Treatment repeats every 3 weeks for up to 6 courses in the absence of unacceptable toxicity or disease progression.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Feasibility and toxicity of the regimen monitored using the Common Toxicity Criteria Version 2.0
时间窗: Up to 3 years
Data will be summarized separately for each dose level, by severity, and type of toxicity.
Maximally tolerated dose of oblimersen sodium
时间窗: 8 days
次要结局
- Potential antitumor activity (responses to therapy)(Up to 3 years)
- Whether concomitant carboplatin and etoposide administration alters oblimersen sodium steady state level(Day 6 and 8)