EUCTR2008-001679-31-CZ进行中（未招募）1 期
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)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •(a) Pathological or cytological confirmation of SCLC;
- •(b) ES-SCLC;
- •(c) 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;
- •(d) No previous chemotherapy;
- •(e) Age =18 years;
- •(f) Eastern Cooperative Oncology Group (ECOG) Performance Status =1;
- •(g) 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 x ULN or ALT/SGPT = 5 x 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;
- •(h) Negative serum or urine pregnancy test result prior to study entry. Women of child-bearing potential and men with partners of child-bearing potential must use a highly effective method of birth control as defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner;;
- •(i) Ability to understand and willingness to sign a written informed consent form.
- •(a) Pathological or cytological confirmation of SCLC;
- •(b) ES-SCLC;
- •(c) 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;
- •(d) No previous chemotherapy;
- •(e) Age =18 years;
- •(f) ECOG Performance Status =2;
- •(g) 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 x ULN or ALT/SGPT = 5 x 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;
- •(h) Negative serum or urine pregnancy test result prior to study entry. Women of child-bearing potential and men with partners of child-bearing potential must use a highly effective method of birth control as defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner;
- •(i) Ability to understand and willingness to sign a written informed consent form.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Phase I and II:
- •(a) Other investigational or commercial agents or therapies administered with the intent to treat the patient’s malignancy;
- •(b) History of allergic reactions attributed to components of the obatoclax formulation (Polysorbate 20 and PEG 300);
- •(c) History of seizure disorders unrelated to SCLC brain metastases, or presence of symptomatic brain metastases;
- •(d) Uncontrolled, intercurrent illness including, but not limited to, symptomatic neurological illness; active, uncontrolled systemic infection considered opportunistic, life-threatening, 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;
- •(e) Pregnant women and women who are breast feeding;
- •(f) human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy.
研究者
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