A Phase I Followed by a Randomized, Phase II Study of Carboplatin and Etoposide With or Without Obatoclax Administered Every 3 Weeks to Patients With Extensive- Stage Small Cell Lung Cancer (ES-SCLC)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 218
- 试验地点
- 75
- 主要终点
- Determine the recommended Phase II dose of obatoclax administered as a 3-hour or 24-hour infusion for 3 consecutive days in Phase I, and response rate in Phase II.
研究概览
简要总结
The Phase I portion of this protocol will determine the best phase II dose and schedule of obatoclax with carboplatin and etoposide in patients with extensive-stage small cell lung cancer. The Phase II portion will evaluate the response rate to this regimen.
详细描述
In the Phase I portion, both 3 hour and 24 hour infusions of obatoclax with carboplatin and etoposide every 3 weeks will be evaluated at different doses. In the Phase II portion, 3 hour infusions of obatoclax with or without carboplatin and etoposide every three weeks will be evaluated for response rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Pathological or cytological confirmation of SCLC
- •Measurable disease using Response Evaluation Criteria in Solid Tumors (RECIST) with at least one lesion ≥2.0 cm using conventional technique or ≥1.0 cm with spiral computed tomography (CT) scan in a single dimension
- •No previous chemotherapy
- •Age ≥18 years
- •Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1
- •Normal organ function defined as: absolute neutrophil count (ANC)
- •1500/mm3, platelets ≥100,000/mm3, total bilirubin ≤ upper limit of normal (ULN) or total bilirubin ≤ 3.0 if liver metastases are present, alanine aminotransferase (serum glutamic pyruvic transaminase) (ALT [SGPT])
- •2.5 ´ ULN or ALT/SGPT ≤ 5 ´ ULN if liver metastases are present, and creatinine within normal institutional limits or calculated creatinine clearance ≥50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- •Negative serum or urine pregnancy test result prior to study entry. In addition, women of child-bearing potential and men with partners of child-bearing potential must agree to use acceptable forms of birth control (those that result in less than 1% pregnancy/year when used correctly: implants, injectables, combined oral contraceptives, some IUDs, vasectomy of a male partner, sexual abstinence)
- •Ability to understand and willingness to sign a written informed consent form
- •Pathological or cytological confirmation of SCLC
- •Measurable disease using RECIST criteria with at least one lesion
- •2.0 cm using conventional technique or ≥1.0 cm with spiral CT scan in a single dimension
- •No previous chemotherapy
- •Age ≥18 years
- •ECOG Performance Status ≤2;
- •Normal organ function defined as: ANC ≥1500/mm3, platelets ≥100,000/mm3, total bilirubin ≤ULN or total bilirubin ≤ 3.0 if liver metastases are present, ALT (SGPT) ≤2.5 ´ ULN or ALT/SGPT ≤ 5 ´ ULN if liver metastases are present, and creatinine within normal institutional limits or calculated creatinine clearance ≥50 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- •Negative serum or urine pregnancy test result prior to study entry. In addition, women of child-bearing potential and men with partners of child-bearing potential must agree to use acceptable forms of birth control (those that result in less than 1% pregnancy/year when used correctly: implants, injectables, combined oral contraceptives, some IUDs, vasectomy of a male partner, sexual abstinence)
- •Ability to understand and willingness to sign a written informed consent form
排除标准
- •Phase I and II:
- •Other investigational or commercial agents or therapies administered with the intent to treat the patient's malignancy
- •History of allergic reactions attributed to components of the obatoclax formulation (Polysorbate 20 and PEG 300)
- •History of seizure disorders unrelated to SCLC brain metastases, or presence of symptomatic brain metastases
- •Uncontrolled,intercurrent illness including, but not limited to, symptomatic neurological illness; active, uncontrolled systemic infection considered opportunistic, lifethreatening,or clinically significant at the time of treatment; symptomatic congestive heart failure; unstable angina pectoris; clinically significant cardiac arrhythmia; significant pulmonary disease or hypoxia; or psychiatric illness/social situations that would limit compliance with study requirements
- •Pregnant women and women who are breast feeding;
- •human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy
研究组 & 干预措施
Phase I A
Obatoclax for 3 hours for 3 days with carboplatin/etoposide.
干预措施: Obatoclax (Drug)
Phase I A
Obatoclax for 3 hours for 3 days with carboplatin/etoposide.
干预措施: Carboplatin/etoposide (Drug)
Phase I B
Obatoclax for 24 hours for 3 days with carboplatin/etoposide.
干预措施: Obatoclax (Drug)
Phase I B
Obatoclax for 24 hours for 3 days with carboplatin/etoposide.
干预措施: Carboplatin/etoposide (Drug)
Phase II A
Obatoclax for 3 hours for 3 days with carboplatin/etoposide.
干预措施: Obatoclax (Drug)
Phase II A
Obatoclax for 3 hours for 3 days with carboplatin/etoposide.
干预措施: Carboplatin/etoposide (Drug)
Phase II B
Carboplatin/etoposide without continued study treatment
干预措施: Carboplatin/etoposide (Drug)
结局指标
主要结局
Determine the recommended Phase II dose of obatoclax administered as a 3-hour or 24-hour infusion for 3 consecutive days in Phase I, and response rate in Phase II.
时间窗: 6 months
次要结局
未报告次要终点