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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)
This study is currently recruiting participants.
Verified by Gemin X, March 2009
First Received: May 20, 2008   Last Updated: March 3, 2009   History of Changes
Sponsored by: Gemin X
Information provided by: Gemin X
ClinicalTrials.gov Identifier: NCT00682981
  Purpose

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.


Condition Intervention Phase
Extensive-Stage Small Cell Lung Cancer
Drug: Obatoclax
Drug: Carboplatin and etoposide
Phase I
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Etoposide Carboplatin Etoposide phosphate Obatoclax mesylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: 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)

Further study details as provided by Gemin X:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 188
Study Start Date: May 2008
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Phase I A: Experimental
Obatoclax for 3 hours for 3 days with carboplatin and etoposide.
Drug: Obatoclax
A 3-hour IV infusion for 3 consecutive days of Obatoclax with carboplatin and etoposide.
Phase I B: Experimental
Obatoclax for 24 hours for 3 days with carboplatin and etoposide.
Drug: Obatoclax
A 24-hour IV infusion for 3 consecutive days of Obatoclax with carboplatin and etoposide.
Phase II A: Experimental
Obatoclax for 3 hours for 3 days with carboplatin and etoposide.
Drug: Obatoclax
A 3-hour IV infusion for 3 consecutive days of Obatoclax with carboplatin and etoposide.
Phase II B: Experimental
Carboplatin and etoposide.
Drug: Carboplatin and etoposide
Carboplatin and etoposide with NO Obatoclax.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00682981

Contacts
Contact: Judy Schnyder 610-640-5735 ext 448 jschnyder@geminx.com
Contact: Danielle Gallagher 610-640-5735 ext 449 dgallagher@geminx.com

  Show 31 Study Locations
Sponsors and Collaborators
Gemin X
Investigators
Study Director: Jean Viallet, MD Gemin X Pharmaceuticals
  More Information

No publications provided

Responsible Party: Gemin X Pharmaceuticals ( Jean Viallet, MD )
Study ID Numbers: GEM017
Study First Received: May 20, 2008
Last Updated: March 3, 2009
ClinicalTrials.gov Identifier: NCT00682981     History of Changes
Health Authority: United States: Food and Drug Administration;   Canada: Health Canada

Keywords provided by Gemin X:
ES-SCLC
Obatoclax

Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Neuroendocrine
Carboplatin
Etoposide phosphate
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Etoposide
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Carcinoma, Neuroendocrine
Antineoplastic Agents
Neoplasms, Nerve Tissue
Carboplatin
Etoposide phosphate
Pharmacologic Actions
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Etoposide
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009