A Phase I/II Study of Carboplatin and Etoposide With or Without Obatoclax in Extensive-stage Small Cell Lung Cancer (ES-SCLC)

This study has been completed.
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Gemin X )
ClinicalTrials.gov Identifier:
NCT00682981
First received: May 20, 2008
Last updated: August 27, 2013
Last verified: August 2013

May 20, 2008
August 27, 2013
May 2008
November 2011   (final data collection date for primary outcome measure)
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. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00682981 on ClinicalTrials.gov Archive Site
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A Phase I/II Study of Carboplatin and Etoposide With or Without Obatoclax in Extensive-stage Small Cell Lung Cancer (ES-SCLC)
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)

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Extensive-stage Small Cell Lung Cancer
  • Drug: Obatoclax
    A 3-hour IV infusion for 3 consecutive days of Obatoclax with carboplatin and etoposide.
    Other Name: GX15-070MS
  • Drug: Obatoclax
    A 24-hour IV infusion for 3 consecutive days of Obatoclax with carboplatin and etoposide.
    Other Name: GX15-070MS
  • Drug: Carboplatin and etoposide
    Carboplatin and etoposide with NO Obatoclax.
    Other Name: Control
  • Experimental: Phase I A
    Obatoclax for 3 hours for 3 days with carboplatin and etoposide.
    Intervention: Drug: Obatoclax
  • Experimental: Phase I B
    Obatoclax for 24 hours for 3 days with carboplatin and etoposide.
    Intervention: Drug: Obatoclax
  • Experimental: Phase II A
    Obatoclax for 3 hours for 3 days with carboplatin and etoposide.
    Intervention: Drug: Obatoclax
  • Experimental: Phase II B
    Carboplatin and etoposide.
    Intervention: Drug: Carboplatin and etoposide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
218
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Bulgaria,   Canada,   Czech Republic,   Hungary,   India,   Poland,   Romania,   Serbia,   United Kingdom
 
NCT00682981
GEM017
No
Teva Pharmaceutical Industries ( Gemin X )
Gemin X
Cephalon
Study Director: Jean Viallet, MD Gemin X Pharmaceuticals
Teva Pharmaceutical Industries
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP