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

Extensive-stage Small Cell Lung Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00682981
• Other study ID #: GEM017
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 20, 2008
• Last updated: July 19, 2016
• Start date: May 2008
• Est. completion date: November 2011

Study information

• Verified date: July 2016
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyCzech Republic: State Institute for Drug ControlHungary: National Institute of PharmacyRomania: National Medicines AgencyBulgaria: Bulgarian Drug AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSerbia: Medicines and Medical Devices Agency of SerbiaIndia: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Extensive-stage Small Cell Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• Obatoclax
IV Infusions for 3 consecutive days of either 3-hours, 2 hours duration
• Carboplatin/etoposide
Carboplatin/etoposide combination

Locations

Country	Name	City	State
Bulgaria	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
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	McGill University	Montreal	Quebec
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
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
India	Vedanta Institute of Medical Sciences	Ahmedabad	Gujarat
India	Jawaharlal Nehru Cancer Hospital and Research Centre	Bhopal	Madhya Pradesh
India	Dr. Kamakshi Memorial Hospital	Chennai	Tamal Nadu
India	Galaxy Cancer Institute, Pushpanjali Crosslay Hospital	Ghaziabad	Uttar Pradesh
India	Kailash Cancer Hospital and Research Centre	Goraj	Gujarat
India	Orchid Nursing Home	Kolkata	West Bengal
India	Curie Manavata Cancer Centre	Nashik	Maharashtra
India	Noble Hospital	Pune	Maharashtra
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
Romania	Prof. Dr. Ion Chiricuta Oncology Institute Cluj Napoca	Cluj
Romania	Oncology Medical Centre SCM	Iasi
Romania	Emergency Clinical County Hospital Oradea	Oradea
Serbia	Center for Pulmonary Diseases, Clinic for Internal Medicine	Kragujevac
Serbia	Institute for Pulmonary Diseases of Vojvodina	Sremska Kamenica
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 States	Center for Cancer and Blood Disorders	Bethesda	Maryland
United States	Iowa Blood and Cancer Center, PLC	Cedar Rapids	Iowa
United States	University of Chicago	Chicago	Illinois
United States	Mid Ohio Oncology/Hematology, Inc.	Columbus	Ohio
United States	Baylor	Dallas	Texas
United States	UT Southwestern Medical Center at Dallas	Dallas	Texas
United States	City of Hope and Beckman Research Institute	Duarte	California
United States	Cancer Centers of the Carolinas	Greenville	South Carolina
United States	Clearview Cancer Institute	Huntsville	Alabama
United States	Integrated Community Oncology Network	Jacksonville	Florida
United States	McLeod Cancer & Blood Center	Johnson City	Tennessee
United States	Kalamazoo Hematology and Oncology	Kalamazoo	Michigan
United States	University of California-San Diego Moores Cancer Center	LaJolla	California
United States	James Brown Cancer Center	Louisville	Kentucky
United States	Northwest Georgia Oncology Centers	Marietta	Georgia
United States	The West Clinic	Memphis	Tennessee
United States	University of Miami-Sylvester Cancer Center	Miami	Florida
United States	Northwest Alabama Cancer Center	Muscle Shoals	Alabama
United States	Florida Cancer Institute	New Port Richey	Florida
United States	Peninsula Cancer Institute	Newport News	Virginia
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	Cancer Care Associates-Oklahoma City	Oklahoma City	Oklahoma
United States	Greater Philadelphia Cancer and Hematology Specialists	Philadelphia	Pennsylvania
United States	University of Pennsylvania Abramson Cancer Center	Philadelphia	Pennsylvania
United States	Mayo Clinic-Arizona	Scottsdale	Arizona
United States	H. Lee Moffitt Cancer Center	Tampa	Florida
United States	Arizona Clinical Research Center	Tucson	Arizona
United States	Cancer Care Associates-Tulsa	Tulsa	Oklahoma
United States	Tyler Cancer Center	Tyler	Texas
United States	Georgetown University Hospital-Lombardi Comprehensive Cancer Center	Washington	District of Columbia
United States	Wheeling Hospital	Wheeling	West Virginia
United States	Cancer Center of Kansas	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Gemin X	Cephalon

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Czech Republic,  Hungary,  India,  Poland,  Romania,  Serbia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes