CompletedPhase 1 / Phase 2NCT00682981

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

StatusCompleted
PhasePhase 1 / Phase 2
U.S. locations75
SponsorGemin X
01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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