A Phase I/II Study of Carboplatin and Etoposide With or Without Obatoclax in Extensive-stage Small Cell Lung Cancer (ES-SCLC)
- Conditions
- Extensive-stage Small Cell Lung Cancer
- Interventions
- Drug: Carboplatin/etoposide
- Registration Number
- NCT00682981
- Lead Sponsor
- Gemin X
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 218
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Phase I B Obatoclax Obatoclax for 24 hours for 3 days with carboplatin/etoposide. Phase I A Carboplatin/etoposide Obatoclax for 3 hours for 3 days with carboplatin/etoposide. Phase II B Carboplatin/etoposide Carboplatin/etoposide without continued study treatment Phase II A Carboplatin/etoposide Obatoclax for 3 hours for 3 days with carboplatin/etoposide. Phase I B Carboplatin/etoposide Obatoclax for 24 hours for 3 days with carboplatin/etoposide. Phase I A Obatoclax Obatoclax for 3 hours for 3 days with carboplatin/etoposide. Phase II A Obatoclax Obatoclax for 3 hours for 3 days with carboplatin/etoposide.
- Primary Outcome Measures
Name Time Method 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. 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (75)
University Of Debrecen Medical and Health Science Centre
🇭🇺Debrecen, Hungary
Orchid Nursing Home
🇮🇳Kolkata, West Bengal, India
Csongrad County Council's Hospital for Chest Diseases
🇭🇺Deszk, Hungary
Vedanta Institute of Medical Sciences
🇮🇳Ahmedabad, Gujarat, India
State Hospital Matrahaza
🇭🇺Matrahaza, Hungary
Jawaharlal Nehru Cancer Hospital and Research Centre
🇮🇳Bhopal, Madhya Pradesh, India
Northwest Alabama Cancer Center
🇺🇸Muscle Shoals, Alabama, United States
Mayo Clinic-Arizona
🇺🇸Scottsdale, Arizona, United States
City of Hope and Beckman Research Institute
🇺🇸Duarte, California, United States
Georgetown University Hospital-Lombardi Comprehensive Cancer Center
🇺🇸Washington, District of Columbia, United States
Integrated Community Oncology Network
🇺🇸Jacksonville, Florida, United States
James Brown Cancer Center
🇺🇸Louisville, Kentucky, United States
Kalamazoo Hematology and Oncology
🇺🇸Kalamazoo, Michigan, United States
Peninsula Cancer Institute
🇺🇸Newport News, Virginia, United States
Baylor
🇺🇸Dallas, Texas, United States
The West Clinic
🇺🇸Memphis, Tennessee, United States
Wheeling Hospital
🇺🇸Wheeling, West Virginia, United States
District Dispensary for Oncology Diseases, Sofia City
🇧🇬Sofia, Bulgaria
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Semmelweis University Medical School, Budapest
🇭🇺Budapest, Hungary
Clinfan Ltd. SMO Tolna County Hospital
🇭🇺Szekszard, Hungary
Wojewodzki Szpital Specjalistyczny im. K. Dluskiego
🇵🇱Bialystok, Poland
Kailash Cancer Hospital and Research Centre
🇮🇳Goraj, Gujarat, India
Dr. Kamakshi Memorial Hospital
🇮🇳Chennai, Tamal Nadu, India
SPZ Gruzlicy i Chorob Pluc
🇵🇱Olsztyn, Poland
Center for Pulmonary Diseases, Clinic for Internal Medicine
🇷🇸Kragujevac, Serbia
Northern Ireland Cancer Centre Queens University Belfast
🇬🇧Belfast, Northern Ireland, United Kingdom
Weston Park Hospital
🇬🇧Sheffield, United Kingdom
University of Chicago
🇺🇸Chicago, Illinois, United States
University of Miami-Sylvester Cancer Center
🇺🇸Miami, Florida, United States
Greater Philadelphia Cancer and Hematology Specialists
🇺🇸Philadelphia, Pennsylvania, United States
Mid Ohio Oncology/Hematology, Inc.
🇺🇸Columbus, Ohio, United States
University of Pennsylvania Abramson Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Cancer Care Associates-Oklahoma City
🇺🇸Oklahoma City, Oklahoma, United States
UT Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
Noble Hospital
🇮🇳Pune, Maharashtra, India
District Dispensary for Cancer Diseases, Plovdiv
🇧🇬Plovdiv, Bulgaria
McGill University
🇨🇦Montreal, Quebec, Canada
Bacs-Kiskun County Hospital
🇭🇺Kecskemet, Hungary
McLeod Cancer & Blood Center
🇺🇸Johnson City, Tennessee, United States
Arizona Clinical Research Center
🇺🇸Tucson, Arizona, United States
Cancer Center of Kansas
🇺🇸Wichita, Kansas, United States
Northwest Georgia Oncology Centers
🇺🇸Marietta, Georgia, United States
Clearview Cancer Institute
🇺🇸Huntsville, Alabama, United States
Florida Cancer Institute
🇺🇸New Port Richey, Florida, United States
University of California-San Diego Moores Cancer Center
🇺🇸LaJolla, California, United States
H. Lee Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy
🇵🇱Otwock, Poland
Iowa Blood and Cancer Center, PLC
🇺🇸Cedar Rapids, Iowa, United States
Center for Cancer and Blood Disorders
🇺🇸Bethesda, Maryland, United States
Cancer Centers of the Carolinas
🇺🇸Greenville, South Carolina, United States
Cancer Care Associates-Tulsa
🇺🇸Tulsa, Oklahoma, United States
Tyler Cancer Center
🇺🇸Tyler, Texas, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
MHAT "Dr. Tota Venkova"
🇧🇬Gabrovo, Bulgaria
Faculty Hospital Ostrava
🇨🇿Ostrava-Poruba, Czech Republic
Curie Manavata Cancer Centre
🇮🇳Nashik, Maharashtra, India
Specialized Hospital for Active Treatment in Oncology
🇧🇬Sofia, Bulgaria
University Hospital Na Bulovce
🇨🇿Prague, Czech Republic
National Institute of Tuberculosis & Pulmonology
🇭🇺Budapest, Hungary
Regional Hospital Kladno
🇨🇿Kladno, Czech Republic
Hospital Kutna Hora
🇨🇿Kutna Hora, Czech Republic
University Hospital Olomouc
🇨🇿Olomouc, Czech Republic
Tom Baker Cancer Centre
🇨🇦Calgary, Alberta, Canada
Royal Bournemouth Hospital
🇬🇧Dorset, United Kingdom
Pest County Hospital
🇭🇺Torokbalint, Hungary
Prof. Dr. Ion Chiricuta Oncology Institute Cluj Napoca
🇷🇴Cluj, Romania
Institute for Pulmonary Diseases of Vojvodina
🇷🇸Sremska Kamenica, Serbia
Galaxy Cancer Institute, Pushpanjali Crosslay Hospital
🇮🇳Ghaziabad, Uttar Pradesh, India
Specjalistyczny Szpital im Prof Alfreda Sokolowskiego
🇵🇱Szczecin-Zdunowo, Poland
Wojewodzki Szpital Chorob Pluc
🇵🇱Wodzislaw Slaski, Poland
Oncology Medical Centre SCM
🇷🇴Iasi, Romania
Emergency Clinical County Hospital Oradea
🇷🇴Oradea, Romania
Nottingham University Hospital
🇬🇧Nottingham, United Kingdom
Royal Surrey County Hospital
🇬🇧Surrey, United Kingdom