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

Condition(s) targeted: Non-Small Cell Lung Cancer

Intervention: bexarotene (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Eisai Medical Research Inc.

Official(s) and/or principal investigator(s):
Mack Mabry, M.D., Study Director, Affiliation: Ligand Pharmaceuticals

Ligand Pharmaceuticals Inc. is studying the use of Targretin capsules (bexarotene) in combination with standard chemotherapy for the treatment of metastatic non-small cell lung cancer in patients who have not yet received chemotherapy for their lung cancer.

Official title: Randomized Phase III Trial Comparing Targretin Capsules/Cisplatin/Vinorelbine Versus Cisplatin/Vinorelbine in Chemotherapy-Naive Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Detailed description: Ligand Pharmaceuticals Inc. is studying the use of Targretin capsules (bexarotene) in combination with Cisplatin and Vinorelbine for the treatment of metastatic non-small cell lung cancer in patients who have not yet received chemotherapy for their lung cancer. In these studies, every patient receives a platinum-containing chemotherapy every four weeks for at least four chemotherapy cycles (approximately four months). Half of the patients are randomly assigned to receive Targretin capsules once daily in addition to the chemotherapy. The other half is randomized to receive a standard platinum-containing chemotherapy without Targretin capsules.

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

Criteria:

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

Nemocnice odd. Onkologie, Ceske Budejovice 370 87, Czech Republic

Pneumologicka klinika 1. LF UK, Praha-6-Veleslavin CZ-160 00, Czech Republic

Klinika pneumologie a hrudni chirurgie 3.LF, Praha-8 CZ-180 00, Czech Republic

University Hospital of Patras, Rio 26500, Greece

7th Pneumonology Clinic, Sotiria Hospital for Diseases of the Chest, Athens 11527, Greece

6th Pneumonology Department, Sotiria Hospital for Diseases of the Chest, Athens 11527, Greece

Fovarosi Onkormanyzat Uzsoki utcai, Korhaza, Budapest 1145, Hungary

Koranyi National Institute for Pulmonology, Budapest 1529, Hungary

Csongrad Megyei Onkormanyzat Mellkasi, Deszk 6772, Hungary

Semmelweis University Department of Pulmonology, Budapest 1125, Hungary

Barzilai Medical Centre, Ashkelon 78308, Israel

Kaplan Medical Center, Rehovot 76100, Israel

Assaf Harofeh Medical Center, Zerifin 70300, Israel

Meir Hospital, Kfar Sava 44281, Israel

Hadassah Medical Center, Jerusalem 19200, Israel

Sheba Medical Center, Tel Hashomer 52620, Israel

Tel-Aviv Sovrasky Medical Center, Tel Aviv 64239, Israel

Akademii Medycznej w Gdansku, Gdansk 80-216, Poland

Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Krakow 31-115, Poland

Wielkopolskie Centrum Chorob Pluc I Gruzlicy, Poznan 66-569, Poland

Instytut Gruzlicy i Chorob Pluc, Warsaw 01-138, Poland

Regionalne Centrum Onkologii, Bialystok 15-027, Poland

Research Institute of Oncology n.a. Hertzen, Moscow 12584, Russian Federation

City Oncology Clinical Center, Moscow 107005, Russian Federation

Central Clinical Hospital n.a. Semashko, Moscow 129128, Russian Federation

Russian Oncology Research Center n.a. Blokhin, Moscow 115478, Russian Federation

City Oncology Hospital #62, Moscow 143423, Russian Federation

City Oncology Center, St. Petersburg 197022, Russian Federation

Research Institute of Oncology n.a. Petrov, St. Petersburg 197758, Russian Federation

St. Petersburg Pavlov State Medical University, St. Petersburg 197089, Russian Federation

Arkhangelsk Regional Oncology Center, Arkhangelsk 163045, Russian Federation

Aberdeen Royal Infirmary, Foresterhill, Aberdeen AB25 2ZN, United Kingdom

Brookwood Medical Center, Birmingham, Alabama 35209, United States

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

University Hospital of Alexandroupolis, Dragana, Alexandroupolis 68100, Greece

Southern Arizona VA Healthcare System, Tucson, Arizona 85723, United States

Canberra Hospital, Garran, Australian Capital Territory 2605, Australia

Arroyo Research Inc., Pasadena, California 91105, United States

Desert Hematology-Oncology Medical Group, Inc., Rancho Mirage, California 92270, United States

Centre Hospitalier Francois Maillot, Briey, Cedex 54150, France

Centre Hospitalier General de Belfort, Belfort, Cedex 90016, France

Centre Hospitalier Intercommunal de la Haute-Saone, Vesoul, Cedex 70014, France

Institut Jean Godinot, Reims, Cedex 51100, France

University General Hospital of Heraklion, Heraklion, Crete, Greece

Chelsea & Westminster Hospital, London, England SW10 9NH, United Kingdom

Bristol Hematology and Oncology Centre, Bristol, England BS2 8ED, United Kingdom

Guys & St. Thomas' Cancer Centre, London, England SE1 9RT, United Kingdom

Leicester Royal Infirmary, Leicester, England LE1 5WW, United Kingdom

New Hope Cancer Center, Hudson, Florida 34667, United States

University of Florida, Gainsville, Florida 32610, United States

Bay Area Cancer Consultants, Palm Harbor, Florida 34684, United States

Veterans Affairs Medical Center, Miami, Florida 33125, United States

Northwest Medical Specialists, Arlington Heights, Illinois 60004, United States

Jayne Gurtler, M.D., APMC, Metairie, Louisiana 70006, United States

Louisiana State University Health Science Center, New Orleans, Louisiana 70112, United States

Cancer Care Manitoba, Winnepeg, Manitoba R3E 0V9, Canada

St. Joseph Mercy Oakland Hospital, Pontiac, Michigan 48341, United States

Capitol Comprehensive Cancer Care Clinic, Jefferson City, Missouri 65109, United States

Port Macquarie Base Hospital, Port Macquarie, New South Wales 2444, Australia

Southern Medical Daycare Centre, Wollongong, New South Wales 2500, Australia

SUNY Downstate Medical Center, Brooklyn, New York 11203, United States

VA Western New York Health Care System, Buffalo, New York 14215, United States

QEII Health Sciences Center, Halifax, Nova Scotia B3H 1V7, Canada

Hematology-Oncology Associates, Toledo, Ohio 43623, United States

Tariq Mahmood, MIdwest City, Oklahoma 73110, United States

Ottawa Regional Cancer Centre, Ottawa, Ontario K1H 1C4, Canada

University of Edinburgh, Edinburgh, Scotland EH4 2XU, United Kingdom

Burnside War Memorial Hospital, Toorak Gardens, South Australia 5065, Australia

Queen Elizabeth Hospital, Woodville, South Australia 5011, Australia

Royal Hobart Hospital, Hobart, Tasmania 7001, Australia

University Oncology & Hematology Associates, Chattanooga, Tennessee 37404, United States

1st Pulmonary Clinic of G. Papanikolaou Hospital, Exochi, Thessaloniki 57010, Greece

2nd Pulmonary Clinic of G. Papanikolaou Hospital, Exochi, Thessaloniki 57010, Greece

Box Hill Hospital, Box Hill, Victoria 3128, Australia

Border Medical Oncology, Wodonga, Victoria 3690, Australia

Marshfield Medical Research Foundation, Marshfield, Wisconsin 54449, United States

Medical Associates Health Centers, Menomonee Falls, Wisconsin 53051, United States

Last updated: April 11, 2007