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

Information source: Teva Pharmaceutical Industries
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Extensive-stage Small Cell Lung Cancer

Intervention: Obatoclax (Drug); Obatoclax (Drug); Obatoclax (Drug); Carboplatin and etoposide (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Gemin X

Official(s) and/or principal investigator(s):
Jean Viallet, MD, Study Director, Affiliation: Gemin X Pharmaceuticals

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.

Clinical Details

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)

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

Primary outcome: 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.

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

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

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, Czech Republic

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, Hungary

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, Poland

Prof. Dr. Ion Chiricuta Oncology Institute Cluj Napoca, Cluj, Romania

Oncology Medical Centre SCM, Iasi, Romania

Emergency Clinical County Hospital Oradea, Oradea, Romania

Center for Pulmonary Diseases, Clinic for Internal Medicine, Kragujevac, Serbia

Institute for Pulmonary Diseases of Vojvodina, Sremska Kamenica, Serbia

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

Clearview Cancer Institute, Huntsville, Alabama 35805, United States

Northwest Alabama Cancer Center, Muscle Shoals, Alabama 35661, United States

Tom Baker Cancer Centre, Calgary, Alberta T2N 4N2, Canada

Cross Cancer Institute, Edmonton, Alberta T6G 1Z2, Canada

Mayo Clinic-Arizona, Scottsdale, Arizona 85259, United States

Arizona Clinical Research Center, Tucson, Arizona 85715, United States

City of Hope and Beckman Research Institute, Duarte, California 91010, United States

University of California-San Diego Moores Cancer Center, LaJolla, California 92093-0987, United States

Georgetown University Hospital-Lombardi Comprehensive Cancer Center, Washington, District of Columbia 20007, United States

Integrated Community Oncology Network, Jacksonville, Florida 32256, United States

University of Miami-Sylvester Cancer Center, Miami, Florida 33136, United States

Florida Cancer Institute, New Port Richey, Florida 34655-1112, United States

H. Lee Moffitt Cancer Center, Tampa, Florida 33612, United States

Northwest Georgia Oncology Centers, Marietta, Georgia 30060, United States

Vedanta Institute of Medical Sciences, Ahmedabad, Gujarat, India

Kailash Cancer Hospital and Research Centre, Goraj, Gujarat, India

University of Chicago, Chicago, Illinois 60637, United States

Iowa Blood and Cancer Center, PLC, Cedar Rapids, Iowa 52402, United States

Cancer Center of Kansas, Wichita, Kansas 67214, United States

James Brown Cancer Center, Louisville, Kentucky 40202, United States

Jawaharlal Nehru Cancer Hospital and Research Centre, Bhopal, Madhya Pradesh, India

Curie Manavata Cancer Centre, Nashik, Maharashtra, India

Noble Hospital, Pune, Maharashtra, India

Center for Cancer and Blood Disorders, Bethesda, Maryland 20817, United States

Kalamazoo Hematology and Oncology, Kalamazoo, Michigan 49048, United States

Northern Ireland Cancer Centre Queens University Belfast, Belfast, Northern Ireland, United Kingdom

Mid Ohio Oncology/Hematology, Inc., Columbus, Ohio 43219, United States

Cancer Care Associates-Oklahoma City, Oklahoma City, Oklahoma 73112, United States

Cancer Care Associates-Tulsa, Tulsa, Oklahoma 74136, United States

Greater Philadelphia Cancer and Hematology Specialists, Philadelphia, Pennsylvania 19114, United States

University of Pennsylvania Abramson Cancer Center, Philadelphia, Pennsylvania 19104, United States

McGill University, Montreal, Quebec H2W 1S6, Canada

Cancer Centers of the Carolinas, Greenville, South Carolina 29605, United States

Dr. Kamakshi Memorial Hospital, Chennai, Tamal Nadu, India

McLeod Cancer & Blood Center, Johnson City, Tennessee 37604, United States

The West Clinic, Memphis, Tennessee 38120, United States

Baylor, Dallas, Texas 75246, United States

UT Southwestern Medical Center at Dallas, Dallas, Texas 75390-8852, United States

Tyler Cancer Center, Tyler, Texas 75702, United States

Galaxy Cancer Institute, Pushpanjali Crosslay Hospital, Ghaziabad, Uttar Pradesh, India

Peninsula Cancer Institute, Newport News, Virginia 23601, United States

Virginia Oncology Associates, Norfolk, Virginia 23502, United States

Orchid Nursing Home, Kolkata, West Bengal, India

Wheeling Hospital, Wheeling, West Virginia 26003, United States

Additional Information

Starting date: May 2008
Last updated: August 27, 2013

Page last updated: August 23, 2015

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