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
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

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 ]

Enrollment: 218
Study Start Date: May 2008
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase I A
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.
Other Name: GX15-070MS
Experimental: Phase I B
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.
Other Name: GX15-070MS
Experimental: Phase II A
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.
Other Name: GX15-070MS
Experimental: Phase II B
Carboplatin and etoposide.
Drug: Carboplatin and etoposide
Carboplatin and etoposide with NO Obatoclax.
Other Name: Control

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Alabama
Clearview Cancer Institute
Huntsville, Alabama, United States, 35805
Northwest Alabama Cancer Center
Muscle Shoals, Alabama, United States, 35661
United States, Arizona
Mayo Clinic-Arizona
Scottsdale, Arizona, United States, 85259
Arizona Clinical Research Center
Tucson, Arizona, United States, 85715
United States, California
City of Hope and Beckman Research Institute
Duarte, California, United States, 91010
University of California-San Diego Moores Cancer Center
LaJolla, California, United States, 92093-0987
United States, District of Columbia
Georgetown University Hospital-Lombardi Comprehensive Cancer Center
Washington, District of Columbia, United States, 20007
United States, Florida
Integrated Community Oncology Network
Jacksonville, Florida, United States, 32256
University of Miami-Sylvester Cancer Center
Miami, Florida, United States, 33136
Florida Cancer Institute
New Port Richey, Florida, United States, 34655-1112
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Northwest Georgia Oncology Centers
Marietta, Georgia, United States, 30060
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Iowa
Iowa Blood and Cancer Center, PLC
Cedar Rapids, Iowa, United States, 52402
United States, Kansas
Cancer Center of Kansas
Wichita, Kansas, United States, 67214
United States, Kentucky
James Brown Cancer Center
Louisville, Kentucky, United States, 40202
United States, Maryland
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
United States, Michigan
Kalamazoo Hematology and Oncology
Kalamazoo, Michigan, United States, 49048
United States, Ohio
Mid Ohio Oncology/Hematology, Inc.
Columbus, Ohio, United States, 43219
United States, Oklahoma
Cancer Care Associates-Oklahoma City
Oklahoma City, Oklahoma, United States, 73112
Cancer Care Associates-Tulsa
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Greater Philadelphia Cancer and Hematology Specialists
Philadelphia, Pennsylvania, United States, 19114
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29605
United States, Tennessee
McLeod Cancer & Blood Center
Johnson City, Tennessee, United States, 37604
The West Clinic
Memphis, Tennessee, United States, 38120
United States, Texas
Baylor
Dallas, Texas, United States, 75246
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390-8852
Tyler Cancer Center
Tyler, Texas, United States, 75702
United States, Virginia
Peninsula Cancer Institute
Newport News, Virginia, United States, 23601
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
United States, West Virginia
Wheeling Hospital
Wheeling, West Virginia, United States, 26003
Bulgaria
MHAT "Dr. Tota Venkova"
Gabrovo, Bulgaria
District Dispensary for Cancer Diseases, Plovdiv
Plovdiv, Bulgaria
Specialized Hospital for Active Treatment in Oncology
Sofia, Bulgaria
District Dispensary for Oncology Diseases, Sofia City
Sofia, Bulgaria
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Quebec
McGill University
Montreal, Quebec, Canada, H2W 1S6
Czech Republic
Regional Hospital Kladno
Kladno, Czech Republic
Hospital Kutna Hora
Kutna Hora, Czech Republic
University Hospital Olomouc
Olomouc, Czech Republic
Faculty Hospital Ostrava
Ostrava-Poruba, Czech Republic
University Hospital Na Bulovce
Prague, Czech Republic
Hungary
National Institute of Tuberculosis & Pulmonology
Budapest, Hungary
Semmelweis University Medical School, Budapest
Budapest, Hungary
University Of Debrecen Medical and Health Science Centre
Debrecen, Hungary
Csongrad County Council's Hospital for Chest Diseases
Deszk, Hungary
Bacs-Kiskun County Hospital
Kecskemet, Hungary
State Hospital Matrahaza
Matrahaza, Hungary
Clinfan Ltd. SMO Tolna County Hospital
Szekszard, Hungary
Pest County Hospital
Torokbalint, Hungary
India
Vedanta Institute of Medical Sciences
Ahmedabad, Gujarat, India
Kailash Cancer Hospital and Research Centre
Goraj, Gujarat, India
Jawaharlal Nehru Cancer Hospital and Research Centre
Bhopal, Madhya Pradesh, India
Curie Manavata Cancer Centre
Nashik, Maharashtra, India
Noble Hospital
Pune, Maharashtra, India
Dr. Kamakshi Memorial Hospital
Chennai, Tamal Nadu, India
Galaxy Cancer Institute, Pushpanjali Crosslay Hospital
Ghaziabad, Uttar Pradesh, India
Orchid Nursing Home
Kolkata, West Bengal, India
Poland
Wojewodzki Szpital Specjalistyczny im. K. Dluskiego
Bialystok, Poland
SPZ Gruzlicy i Chorob Pluc
Olsztyn, Poland
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
Otwock, Poland
Specjalistyczny Szpital im Prof Alfreda Sokolowskiego
Szczecin-Zdunowo, Poland
Wojewodzki Szpital Chorob Pluc
Wodzislaw Slaski, Poland
Romania
Prof. Dr. Ion Chiricuta Oncology Institute Cluj Napoca
Cluj, Romania
Oncology Medical Centre SCM
Iasi, Romania
Emergency Clinical County Hospital Oradea
Oradea, Romania
Serbia
Center for Pulmonary Diseases, Clinic for Internal Medicine
Kragujevac, Serbia
Institute for Pulmonary Diseases of Vojvodina
Sremska Kamenica, Serbia
United Kingdom
Northern Ireland Cancer Centre Queens University Belfast
Belfast, Northern Ireland, United Kingdom
Royal Bournemouth Hospital
Dorset, United Kingdom
Nottingham University Hospital
Nottingham, United Kingdom
Weston Park Hospital
Sheffield, United Kingdom
Royal Surrey County Hospital
Surrey, United Kingdom
Sponsors and Collaborators
Gemin X
Cephalon
Investigators
Study Director: Jean Viallet, MD Gemin X Pharmaceuticals
  More Information

No publications provided by Teva Pharmaceutical Industries

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Teva Pharmaceutical Industries ( Gemin X )
ClinicalTrials.gov Identifier: NCT00682981     History of Changes
Other Study ID Numbers: GEM017
Study First Received: May 20, 2008
Last Updated: August 27, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Romania: National Medicines Agency
Bulgaria: Bulgarian Drug Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Serbia: Medicines and Medical Devices Agency of Serbia
India: Drugs Controller General of India

Keywords provided by Teva Pharmaceutical Industries:
ES-SCLC
Obatoclax

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Carboplatin
Etoposide
Etoposide phosphate
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 29, 2014