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)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 0

Inclusion Criteria

Phase I:
(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.

Phase II:
(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

Exclusion Criteria

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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