A Phase I/II Study of Carboplatin and Etoposide With or Without Obatoclax in Extensive-stage Small Cell Lung Cancer (ES-SCLC)
NCT ID: NCT00682981
Last Updated: 2016-07-21
Study Results
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Basic Information
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COMPLETED
PHASE1/PHASE2
218 participants
INTERVENTIONAL
2008-05-31
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Phase I A
Obatoclax for 3 hours for 3 days with carboplatin/etoposide.
Obatoclax
IV Infusions for 3 consecutive days of either 3-hours, 2 hours duration
Carboplatin/etoposide
Carboplatin/etoposide combination
Phase I B
Obatoclax for 24 hours for 3 days with carboplatin/etoposide.
Obatoclax
IV Infusions for 3 consecutive days of either 3-hours, 2 hours duration
Carboplatin/etoposide
Carboplatin/etoposide combination
Phase II A
Obatoclax for 3 hours for 3 days with carboplatin/etoposide.
Obatoclax
IV Infusions for 3 consecutive days of either 3-hours, 2 hours duration
Carboplatin/etoposide
Carboplatin/etoposide combination
Phase II B
Carboplatin/etoposide without continued study treatment
Carboplatin/etoposide
Carboplatin/etoposide combination
Interventions
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Obatoclax
IV Infusions for 3 consecutive days of either 3-hours, 2 hours duration
Carboplatin/etoposide
Carboplatin/etoposide combination
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Cephalon
INDUSTRY
Gemin X
INDUSTRY
Responsible Party
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Principal Investigators
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Jean Viallet, MD
Role: STUDY_DIRECTOR
Gemin X Pharmaceuticals
Locations
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Clearview Cancer Institute
Huntsville, Alabama, United States
Northwest Alabama Cancer Center
Muscle Shoals, Alabama, United States
Mayo Clinic-Arizona
Scottsdale, Arizona, United States
Arizona Clinical Research Center
Tucson, Arizona, United States
City of Hope and Beckman Research Institute
Duarte, California, United States
University of California-San Diego Moores Cancer Center
La Jolla, California, United States
Georgetown University Hospital-Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States
Integrated Community Oncology Network
Jacksonville, Florida, United States
University of Miami-Sylvester Cancer Center
Miami, Florida, United States
Florida Cancer Institute
New Port Richey, Florida, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
Northwest Georgia Oncology Centers
Marietta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Iowa Blood and Cancer Center, PLC
Cedar Rapids, Iowa, United States
Cancer Center of Kansas
Wichita, Kansas, United States
James Brown Cancer Center
Louisville, Kentucky, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Kalamazoo Hematology and Oncology
Kalamazoo, Michigan, United States
Mid Ohio Oncology/Hematology, Inc.
Columbus, Ohio, United States
Cancer Care Associates-Oklahoma City
Oklahoma City, Oklahoma, United States
Cancer Care Associates-Tulsa
Tulsa, Oklahoma, United States
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Greater Philadelphia Cancer and Hematology Specialists
Philadelphia, Pennsylvania, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, United States
McLeod Cancer & Blood Center
Johnson City, Tennessee, United States
The West Clinic
Memphis, Tennessee, United States
Baylor
Dallas, Texas, United States
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States
Tyler Cancer Center
Tyler, Texas, United States
Peninsula Cancer Institute
Newport News, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Wheeling Hospital
Wheeling, West Virginia, United States
MHAT "Dr. Tota Venkova"
Gabrovo, , Bulgaria
District Dispensary for Cancer Diseases, Plovdiv
Plovdiv, , Bulgaria
District Dispensary for Oncology Diseases, Sofia City
Sofia, , Bulgaria
Specialized Hospital for Active Treatment in Oncology
Sofia, , Bulgaria
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
McGill University
Montreal, Quebec, Canada
Regional Hospital Kladno
Kladno, , Czechia
Hospital Kutna Hora
Kutná Hora, , Czechia
University Hospital Olomouc
Olomouc, , Czechia
Faculty Hospital Ostrava
Ostrava-Poruba, , Czechia
University Hospital Na Bulovce
Prague, , Czechia
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
Kecskemét, , Hungary
State Hospital Matrahaza
Mátraháza, , Hungary
Clinfan Ltd. SMO Tolna County Hospital
Szekszárd, , Hungary
Pest County Hospital
Törökbálint, , Hungary
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
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
Wodzisław Śląski, , Poland
Prof. Dr. Ion Chiricuta Oncology Institute Cluj Napoca
Cluj-Napoca, , Romania
Oncology Medical Centre SCM
Iași, , Romania
Emergency Clinical County Hospital Oradea
Oradea, , Romania
Institute for Pulmonary Diseases of Vojvodina
Kamenitz, , Serbia
Center for Pulmonary Diseases, Clinic for Internal Medicine
Kragujevac, , Serbia
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
Countries
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References
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Langer CJ, Albert I, Ross HJ, Kovacs P, Blakely LJ, Pajkos G, Somfay A, Zatloukal P, Kazarnowicz A, Moezi MM, Schreeder MT, Schnyder J, Ao-Baslock A, Pathak AK, Berger MS; GEM017 Investigators. Randomized phase II study of carboplatin and etoposide with or without obatoclax mesylate in extensive-stage small cell lung cancer. Lung Cancer. 2014 Sep;85(3):420-8. doi: 10.1016/j.lungcan.2014.05.003. Epub 2014 May 13.
Other Identifiers
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GEM017
Identifier Type: -
Identifier Source: org_study_id
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