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

This study has been completed.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00050973
First received: December 31, 2002
Last updated: May 13, 2013
Last verified: July 2008
  Purpose

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.


Condition Intervention Phase
Non-small Cell Lung Cancer
Drug: bexarotene
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Enrollment: 623
Study Completion Date: March 2005
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Detailed Description:

This study evaluates 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. 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00050973

  Hide Study Locations
Locations
United States, Alabama
Brookwood Medical Center
Birmingham, Alabama, United States, 35209
United States, Arizona
Southern Arizona VA Healthcare System
Tucson, Arizona, United States, 85723
United States, California
Arroyo Research Inc.
Pasadena, California, United States, 91105
Desert Hematology-Oncology Medical Group, Inc.
Rancho Mirage, California, United States, 92270
United States, Florida
University of Florida
Gainsville, Florida, United States, 32610
New Hope Cancer Center
Hudson, Florida, United States, 34667
Veterans Affairs Medical Center
Miami, Florida, United States, 33125
Bay Area Cancer Consultants
Palm Harbor, Florida, United States, 34684
United States, Illinois
Northwest Medical Specialists
Arlington Heights, Illinois, United States, 60004
United States, Louisiana
Jayne Gurtler, M.D., APMC
Metairie, Louisiana, United States, 70006
Louisiana State University Health Science Center
New Orleans, Louisiana, United States, 70112
United States, Michigan
St. Joseph Mercy Oakland Hospital
Pontiac, Michigan, United States, 48341
United States, Missouri
Capitol Comprehensive Cancer Care Clinic
Jefferson City, Missouri, United States, 65109
United States, New York
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
VA Western New York Health Care System
Buffalo, New York, United States, 14215
United States, Ohio
Hematology-Oncology Associates
Toledo, Ohio, United States, 43623
United States, Oklahoma
Tariq Mahmood
MIdwest City, Oklahoma, United States, 73110
United States, Tennessee
University Oncology & Hematology Associates
Chattanooga, Tennessee, United States, 37404
United States, Wisconsin
Marshfield Medical Research Foundation
Marshfield, Wisconsin, United States, 54449
Medical Associates Health Centers
Menomonee Falls, Wisconsin, United States, 53051
Australia, Australian Capital Territory
Canberra Hospital
Garran, Australian Capital Territory, Australia, 2605
Australia, New South Wales
Port Macquarie Base Hospital
Port Macquarie, New South Wales, Australia, 2444
Southern Medical Daycare Centre
Wollongong, New South Wales, Australia, 2500
Australia, South Australia
Burnside War Memorial Hospital
Toorak Gardens, South Australia, Australia, 5065
Queen Elizabeth Hospital
Woodville, South Australia, Australia, 5011
Australia, Tasmania
Royal Hobart Hospital
Hobart, Tasmania, Australia, 7001
Australia, Victoria
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Border Medical Oncology
Wodonga, Victoria, Australia, 3690
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Canada, Manitoba
Cancer Care Manitoba
Winnepeg, Manitoba, Canada, R3E 0V9
Canada, Nova Scotia
QEII Health Sciences Center
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 1C4
Czech Republic
Nemocnice odd. Onkologie
Ceske Budejovice, Czech Republic, 370 87
Pneumologicka klinika 1. LF UK
Praha-6-Veleslavin, Czech Republic, CZ-160 00
Klinika pneumologie a hrudni chirurgie 3.LF
Praha-8, Czech Republic, CZ-180 00
France
Centre Hospitalier General de Belfort
Belfort, Cedex, France, 90016
Centre Hospitalier Francois Maillot
Briey, Cedex, France, 54150
Institut Jean Godinot
Reims, Cedex, France, 51100
Centre Hospitalier Intercommunal de la Haute-Saone
Vesoul, Cedex, France, 70014
Greece
University Hospital of Alexandroupolis
Dragana, Alexandroupolis, Greece, 68100
University General Hospital of Heraklion
Heraklion, Crete, Greece
1st Pulmonary Clinic of G. Papanikolaou Hospital
Exochi, Thessaloniki, Greece, 57010
2nd Pulmonary Clinic of G. Papanikolaou Hospital
Exochi, Thessaloniki, Greece, 57010
7th Pneumonology Clinic, Sotiria Hospital for Diseases of the Chest
Athens, Greece, 11527
6th Pneumonology Department, Sotiria Hospital for Diseases of the Chest
Athens, Greece, 11527
University Hospital of Patras
Rio, Greece, 26500
Hungary
Fovarosi Onkormanyzat Uzsoki utcai, Korhaza
Budapest, Hungary, 1145
Koranyi National Institute for Pulmonology
Budapest, Hungary, 1529
Semmelweis University Department of Pulmonology
Budapest, Hungary, 1125
Csongrad Megyei Onkormanyzat Mellkasi
Deszk, Hungary, 6772
Israel
Barzilai Medical Centre
Ashkelon, Israel, 78308
Hadassah Medical Center
Jerusalem, Israel, 19200
Meir Hospital
Kfar Sava, Israel, 44281
Kaplan Medical Center
Rehovot, Israel, 76100
Tel-Aviv Sovrasky Medical Center
Tel Aviv, Israel, 64239
Sheba Medical Center
Tel Hashomer, Israel, 52620
Assaf Harofeh Medical Center
Zerifin, Israel, 70300
Poland
Regionalne Centrum Onkologii
Bialystok, Poland, 15-027
Akademii Medycznej w Gdansku
Gdansk, Poland, 80-216
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie
Krakow, Poland, 31-115
Wielkopolskie Centrum Chorob Pluc I Gruzlicy
Poznan, Poland, 66-569
Instytut Gruzlicy i Chorob Pluc
Warsaw, Poland, 01-138
Russian Federation
Arkhangelsk Regional Oncology Center
Arkhangelsk, Russian Federation, 163045
Central Clinical Hospital n.a. Semashko
Moscow, Russian Federation, 129128
Research Institute of Oncology n.a. Hertzen
Moscow, Russian Federation, 12584
Russian Oncology Research Center n.a. Blokhin
Moscow, Russian Federation, 115478
City Oncology Clinical Center
Moscow, Russian Federation, 107005
City Oncology Hospital #62
Moscow, Russian Federation, 143423
St. Petersburg Pavlov State Medical University
St. Petersburg, Russian Federation, 197089
City Oncology Center
St. Petersburg, Russian Federation, 197022
Research Institute of Oncology n.a. Petrov
St. Petersburg, Russian Federation, 197758
United Kingdom
Aberdeen Royal Infirmary
Foresterhill, Aberdeen, United Kingdom, AB25 2ZN
Bristol Hematology and Oncology Centre
Bristol, England, United Kingdom, BS2 8ED
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE1 5WW
Chelsea & Westminster Hospital
London, England, United Kingdom, SW10 9NH
Guys & St. Thomas' Cancer Centre
London, England, United Kingdom, SE1 9RT
University of Edinburgh
Edinburgh, Scotland, United Kingdom, EH4 2XU
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Mack Mabry, M.D. Ligand Pharmaceuticals
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00050973     History of Changes
Obsolete Identifiers: NCT00030927
Other Study ID Numbers: L1069-49
Study First Received: December 31, 2002
Last Updated: May 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
NSCLC
Targretin
Retinoid
Bexarotene

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Bexarotene
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014