A Phase I/II Study of Carboplatin and Etoposide With or Without Obatoclax in Extensive-stage Small Cell Lung Cancer (ES-SCLC)
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.
Checked against the public recordLast updated Jul 21, 2016 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Gemin X
- Interventions being studied
- Drug: Obatoclax; Drug: Carboplatin/etoposide
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: Phase I: * Pathological or cytological confirmation of SCLC * ES-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 Phase II: * Pathological or cytological confirmation of SCLC * ES-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 Exclusion Criteria: 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Clearview Cancer InstituteHuntsville, Alabama
- Northwest Alabama Cancer CenterMuscle Shoals, Alabama
- Mayo Clinic-ArizonaScottsdale, Arizona
- Arizona Clinical Research CenterTucson, Arizona
- City of Hope and Beckman Research InstituteDuarte, California
- University of California-San Diego Moores Cancer CenterLa Jolla, California
- Georgetown University Hospital-Lombardi Comprehensive Cancer CenterWashington D.C., District of Columbia
- Integrated Community Oncology NetworkJacksonville, Florida
- University of Miami-Sylvester Cancer CenterMiami, Florida
- Florida Cancer InstituteNew Port Richey, Florida
- H. Lee Moffitt Cancer CenterTampa, Florida
- Northwest Georgia Oncology CentersMarietta, Georgia
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 21, 2016. Always confirm current availability with the study team.