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

July 19, 2016 updated by: Gemin X

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

218

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase I A
Obatoclax for 3 hours for 3 days with carboplatin/etoposide.
Drug: Obatoclax
IV Infusions for 3 consecutive days of either 3-hours, 2 hours duration
Other Names:
  • GX15-070MS
Drug: Carboplatin/etoposide
Carboplatin/etoposide combination
Other Names:
  • Control
Experimental: Phase I B
Obatoclax for 24 hours for 3 days with carboplatin/etoposide.
Drug: Obatoclax
IV Infusions for 3 consecutive days of either 3-hours, 2 hours duration
Other Names:
  • GX15-070MS
Drug: Carboplatin/etoposide
Carboplatin/etoposide combination
Other Names:
  • Control
Experimental: Phase II A
Obatoclax for 3 hours for 3 days with carboplatin/etoposide.
Drug: Obatoclax
IV Infusions for 3 consecutive days of either 3-hours, 2 hours duration
Other Names:
  • GX15-070MS
Drug: Carboplatin/etoposide
Carboplatin/etoposide combination
Other Names:
  • Control
Active Comparator: Phase II B
Carboplatin/etoposide without continued study treatment
Drug: Carboplatin/etoposide
Carboplatin/etoposide combination
Other Names:
  • Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gemin X

Collaborators

Cephalon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

May 20, 2008

First Submitted That Met QC Criteria

May 22, 2008

First Posted (Estimate)

May 23, 2008

Study Record Updates

Last Update Posted (Estimate)

July 21, 2016

Last Update Submitted That Met QC Criteria

July 19, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEM017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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