Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell Lung Cancer

NCT00050973 | Completed Phase 3

• 1 other identifier: L1069-49
• Study Type: interventional
• Target: 623
• Locations: 11 countries
• Sites: 77

Brief Summary

This study evaluates the use of Targretin capsules (bexarotene) in combination with standard chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) in patients who have not yet received chemotherapy for their lung cancer.

Conditions

Non-small Cell Lung Cancer

Keywords

NSCLC; Targretin; Retinoid; Bexarotene

Interventions

bexarotene DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Patients must have: * Pathologic (histologic or cytologic) confirmation of NSCLC * Stage IIIB with malignant pleural effusion or Stage IV disease * At least one measurable or evaluable NSCLC lesion that has not been previously irradiated unless radiation therapy was more than three weeks prior to entry in the study and the lesion has been shown to have progressed subsequent to the radiation therapy * ECOG performance status 0 or 1 * Adequate organ system function * Fasting serum triglycerides that are within the age-adjusted normal range (or normalized with appropriate intervention such as antilipid therapy prior to the initiation of Targretin capsule therapy). Patients must be able to complete at least four cycles of combination chemotherapy (i.e., approximately four months) Patients must not have had: * Brain metastasis * Prior chemotherapy for NSCLC * Prior platinum-based chemotherapy for any indication

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (77)

Brookwood Medical Center

Birmingham, Alabama, 35209, United States

Location

Southern Arizona VA Healthcare System

Tucson, Arizona, 85723, United States

Location

Arroyo Research Inc.

Pasadena, California, 91105, United States

Location

Desert Hematology-Oncology Medical Group, Inc.

Rancho Mirage, California, 92270, United States

Location

University of Florida

Gainsville, Florida, 32610, United States

Location

New Hope Cancer Center

Hudson, Florida, 34667, United States

Location

Veterans Affairs Medical Center

Miami, Florida, 33125, United States

Location

Bay Area Cancer Consultants

Palm Harbor, Florida, 34684, United States

Location

Northwest Medical Specialists

Arlington Heights, Illinois, 60004, United States

Location

Jayne Gurtler, M.D., APMC

Metairie, Louisiana, 70006, United States

Location

Louisiana State University Health Science Center

New Orleans, Louisiana, 70112, United States

Location

St. Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341, United States

Location

Capitol Comprehensive Cancer Care Clinic

Jefferson City, Missouri, 65109, United States

Location

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

VA Western New York Health Care System

Buffalo, New York, 14215, United States

Location

Hematology-Oncology Associates

Toledo, Ohio, 43623, United States

Location

Tariq Mahmood

Midwest City, Oklahoma, 73110, United States

Location

University Oncology & Hematology Associates

Chattanooga, Tennessee, 37404, United States

Location

Marshfield Medical Research Foundation

Marshfield, Wisconsin, 54449, United States

Location

Medical Associates Health Centers

Menomonee Falls, Wisconsin, 53051, United States

Location

Canberra Hospital

Garran, Australian Capital Territory, 2605, Australia

Location

Port Macquarie Base Hospital

Port Macquarie, New South Wales, 2444, Australia

Location

Southern Medical Daycare Centre

Wollongong, New South Wales, 2500, Australia

Location

Burnside War Memorial Hospital

Toorak Gardens, South Australia, 5065, Australia

Location

Queen Elizabeth Hospital

Woodville, South Australia, 5011, Australia

Location

Royal Hobart Hospital

Hobart, Tasmania, 7001, Australia

Location

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

Location

Border Medical Oncology

Wodonga, Victoria, 3690, Australia

Location

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Cancer Care Manitoba

Winnepeg, Manitoba, R3E 0V9, Canada

Location

QEII Health Sciences Center

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Ottawa Regional Cancer Centre

Ottawa, Ontario, K1H 1C4, Canada

Location

Nemocnice odd. Onkologie

České Budějovice, 370 87, Czechia

Location

Pneumologicka klinika 1. LF UK

Praha-6-Veleslavin, CZ-160 00, Czechia

Location

Klinika pneumologie a hrudni chirurgie 3.LF

Praha-8, CZ-180 00, Czechia

Location

Centre Hospitalier General de Belfort

Belfort, Cedex, 90016, France

Location

Centre Hospitalier Francois Maillot

Briey, Cedex, 54150, France

Location

Institut Jean Godinot

Reims, Cedex, 51100, France

Location

Centre Hospitalier Intercommunal de la Haute-Saone

Vesoul, Cedex, 70014, France

Location

University Hospital of Alexandroupolis

Dragana, Alexandroupolis, 68100, Greece

Location

University General Hospital of Heraklion

Heraklion, Crete, Greece

Location

1st Pulmonary Clinic of G. Papanikolaou Hospital

Exochi, Thessaloniki, 57010, Greece

Location

2nd Pulmonary Clinic of G. Papanikolaou Hospital

Exochi, Thessaloniki, 57010, Greece

Location

6th Pneumonology Department, Sotiria Hospital for Diseases of the Chest

Athens, 11527, Greece

Location

7th Pneumonology Clinic, Sotiria Hospital for Diseases of the Chest

Athens, 11527, Greece

Location

University Hospital of Patras

Rio, 26500, Greece

Location

Semmelweis University Department of Pulmonology

Budapest, 1125, Hungary

Location

Fovarosi Onkormanyzat Uzsoki utcai, Korhaza

Budapest, 1145, Hungary

Location

Koranyi National Institute for Pulmonology

Budapest, 1529, Hungary

Location

Csongrad Megyei Onkormanyzat Mellkasi

Deszk, 6772, Hungary

Location

Barzilai Medical Centre

Ashkelon, 78308, Israel

Location

Hadassah Medical Center

Jerusalem, 19200, Israel

Location

Meir Hospital

Kfar Saba, 44281, Israel

Location

Kaplan Medical Center

Rehovot, 76100, Israel

Location

Tel-Aviv Sovrasky Medical Center

Tel Aviv, 64239, Israel

Location

Sheba Medical Center

Tel Litwinsky, 52620, Israel

Location

Assaf Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

Regionalne Centrum Onkologii

Bialystok, 15-027, Poland

Location

Akademii Medycznej w Gdansku

Gdansk, 80-216, Poland

Location

Centrum Onkologii Instytut im. M. Sklodowskiej-Curie

Krakow, 31-115, Poland

Location

Wielkopolskie Centrum Chorob Pluc I Gruzlicy

Poznan, 66-569, Poland

Location

Instytut Gruzlicy i Chorob Pluc

Warsaw, 01-138, Poland

Location

Arkhangelsk Regional Oncology Center

Arkhangelsk, 163045, Russia

Location

City Oncology Clinical Center

Moscow, 107005, Russia

Location

Russian Oncology Research Center n.a. Blokhin

Moscow, 115478, Russia

Location

Research Institute of Oncology n.a. Hertzen

Moscow, 12584, Russia

Location

Central Clinical Hospital n.a. Semashko

Moscow, 129128, Russia

Location

City Oncology Hospital #62

Moscow, 143423, Russia

Location

City Oncology Center

Saint Petersburg, 197022, Russia

Location

St. Petersburg Pavlov State Medical University

Saint Petersburg, 197089, Russia

Location

Research Institute of Oncology n.a. Petrov

Saint Petersburg, 197758, Russia

Location

Aberdeen Royal Infirmary

Foresterhill, Aberdeen, AB25 2ZN, United Kingdom

Location

Bristol Hematology and Oncology Centre

Bristol, England, BS2 8ED, United Kingdom

Location

Leicester Royal Infirmary

Leicester, England, LE1 5WW, United Kingdom

Location

Guys & St. Thomas' Cancer Centre

London, England, SE1 9RT, United Kingdom

Location

Chelsea & Westminster Hospital

London, England, SW10 9NH, United Kingdom

Location

University of Edinburgh

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Bexarotene

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Mack Mabry, M.D.

  Ligand Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 31, 2002
• First Posted: January 3, 2003
• Primary Completion: November 1, 2004
• Study Completion: March 1, 2005
• Last Updated: May 14, 2013

Record last verified: 2008-07

Locations

CZ (3); IL (7); FR (4); RU (9); GR (7); GB (6); PL (5); US (20); AU (8); CA (4); HU (4)