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Extensive-stage Small Cell Lung CancerPhase 1/2NCT00682981

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

A Phase 1/2 study testing Obatoclax and Carboplatin/etoposide in people with Extensive-stage Small Cell Lung Cancer, run by Gemin X at 75 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Extensive-stage Small Cell Lung Cancer
What is being tested?
Obatoclax and Carboplatin/etoposide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
218 participants
Where
75 sitesin 10 countries
Study dates
May 2008to Nov 2011
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 23Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

75 sites in 10 countries.

75 sites in 10 countries

United States32 sites

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817

  • Iowa Blood and Cancer Center, PLC

    Cedar Rapids, Iowa, 52402

  • University of Chicago

    Chicago, Illinois, 60637

  • Mid Ohio Oncology/Hematology, Inc.

    Columbus, Ohio, 43219

  • Baylor

    Dallas, Texas, 75246

  • UT Southwestern Medical Center at Dallas

    Dallas, Texas, 75390-8852

  • City of Hope and Beckman Research Institute

    Duarte, California, 91010

  • Cancer Centers of the Carolinas

    Greenville, South Carolina, 29605

  • Clearview Cancer Institute

    Huntsville, Alabama, 35805

  • Integrated Community Oncology Network

    Jacksonville, Florida, 32256

  • McLeod Cancer & Blood Center

    Johnson City, Tennessee, 37604

  • Kalamazoo Hematology and Oncology

    Kalamazoo, Michigan, 49048

  • University of California-San Diego Moores Cancer Center

    La Jolla, California, 92093-0987

  • James Brown Cancer Center

    Louisville, Kentucky, 40202

  • Northwest Georgia Oncology Centers

    Marietta, Georgia, 30060

  • The West Clinic

    Memphis, Tennessee, 38120

  • University of Miami-Sylvester Cancer Center

    Miami, Florida, 33136

  • Northwest Alabama Cancer Center

    Muscle Shoals, Alabama, 35661

  • Florida Cancer Institute

    New Port Richey, Florida, 34655-1112

  • Peninsula Cancer Institute

    Newport News, Virginia, 23601

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Cancer Care Associates-Oklahoma City

    Oklahoma City, Oklahoma, 73112

  • University of Pennsylvania Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Greater Philadelphia Cancer and Hematology Specialists

    Philadelphia, Pennsylvania, 19114

  • Mayo Clinic-Arizona

    Scottsdale, Arizona, 85259

  • H. Lee Moffitt Cancer Center

    Tampa, Florida, 33612

  • Arizona Clinical Research Center

    Tucson, Arizona, 85715

  • Cancer Care Associates-Tulsa

    Tulsa, Oklahoma, 74136

  • Tyler Cancer Center

    Tyler, Texas, 75702

  • Georgetown University Hospital-Lombardi Comprehensive Cancer Center

    Washington D.C., District of Columbia, 20007

  • Wheeling Hospital

    Wheeling, West Virginia, 26003

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

Other trials in United States

Hungary8 sites

  • National Institute of Tuberculosis & Pulmonology

    Budapest

  • Semmelweis University Medical School, Budapest

    Budapest

  • University Of Debrecen Medical and Health Science Centre

    Debrecen

  • Csongrad County Council's Hospital for Chest Diseases

    Deszk

  • Bacs-Kiskun County Hospital

    Kecskemét

  • State Hospital Matrahaza

    Mátraháza

  • Clinfan Ltd. SMO Tolna County Hospital

    Szekszárd

  • Pest County Hospital

    Törökbálint

Other trials in Hungary

India8 sites

  • Vedanta Institute of Medical Sciences

    Ahmedabad, Gujarat

  • Jawaharlal Nehru Cancer Hospital and Research Centre

    Bhopal, Madhya Pradesh

  • Dr. Kamakshi Memorial Hospital

    Chennai, Tamal Nadu

  • Galaxy Cancer Institute, Pushpanjali Crosslay Hospital

    Ghaziabad, Uttar Pradesh

  • Kailash Cancer Hospital and Research Centre

    Goraj, Gujarat

  • Orchid Nursing Home

    Kolkata, West Bengal

  • Curie Manavata Cancer Centre

    Nashik, Maharashtra

  • Noble Hospital

    Pune, Maharashtra

Other trials in India

Czechia5 sites

  • Regional Hospital Kladno

    Kladno

  • Hospital Kutna Hora

    Kutná Hora

  • University Hospital Olomouc

    Olomouc

  • Faculty Hospital Ostrava

    Ostrava-Poruba

  • University Hospital Na Bulovce

    Prague

Other trials in Czechia

Poland5 sites

  • Wojewodzki Szpital Specjalistyczny im. K. Dluskiego

    Bialystok

  • SPZ Gruzlicy i Chorob Pluc

    Olsztyn

  • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

    Otwock

  • Specjalistyczny Szpital im Prof Alfreda Sokolowskiego

    Szczecin-Zdunowo

  • Wojewodzki Szpital Chorob Pluc

    Wodzisław Śląski

Other trials in Poland

United Kingdom5 sites

  • Northern Ireland Cancer Centre Queens University Belfast

    Belfast, Northern Ireland

  • Royal Bournemouth Hospital

    Dorset

  • Nottingham University Hospital

    Nottingham

  • Weston Park Hospital

    Sheffield

  • Royal Surrey County Hospital

    Surrey

Other trials in United Kingdom

Bulgaria4 sites

  • MHAT "Dr. Tota Venkova"

    Gabrovo

  • District Dispensary for Cancer Diseases, Plovdiv

    Plovdiv

  • District Dispensary for Oncology Diseases, Sofia City

    Sofia

  • Specialized Hospital for Active Treatment in Oncology

    Sofia

Other trials in Bulgaria

Canada3 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • McGill University

    Montreal, Quebec, H2W 1S6

Other trials in Canada

Romania3 sites

  • Prof. Dr. Ion Chiricuta Oncology Institute Cluj Napoca

    Cluj-Napoca

  • Oncology Medical Centre SCM

    Iași

  • Emergency Clinical County Hospital Oradea

    Oradea

Other trials in Romania

Serbia2 sites

  • Institute for Pulmonary Diseases of Vojvodina

    Kamenitz

  • Center for Pulmonary Diseases, Clinic for Internal Medicine

    Kragujevac

Other trials in Serbia

About this study

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)

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.

Read the 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.

Being tested
Obatoclax, Carboplatin/etoposide
Keywords
ES-SCLC, Obatoclax
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObatoclaxDrug

    Also called GX15-070MS

    IV Infusions for 3 consecutive days of either 3-hours, 2 hours duration

  • Carboplatin/etoposideDrug

    Also called Control

    Carboplatin/etoposide combination

Study groups in NCT00682981
Study groupRoleWhat they receive
Phase I AExperimentalObatoclax for 3 hours for 3 days with carboplatin/etoposide.
Receives: Drug: Obatoclax; Drug: Carboplatin/etoposide
Phase I BExperimentalObatoclax for 24 hours for 3 days with carboplatin/etoposide.
Receives: Drug: Obatoclax; Drug: Carboplatin/etoposide
Phase II AExperimentalObatoclax for 3 hours for 3 days with carboplatin/etoposide.
Receives: Drug: Obatoclax; Drug: Carboplatin/etoposide
Phase II BActive comparatorCarboplatin/etoposide without continued study treatment
Receives: Drug: Carboplatin/etoposide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionNov 2011
  4. Study completionNov 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
218 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00682981
Sponsor's protocol ID
GEM017
Status last verified
Jul 2016
First submitted
20 May 2008
Last updated
21 Jul 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 24997137

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Obatoclax and Carboplatin/etoposide in people with Extensive-stage Small Cell Lung Cancer, run by Gemin X at 75 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 75 sites in United States, Hungary, India, Czechia, Poland and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00682981, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2016.

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