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

Primary Purpose

Non-small Cell Lung Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
bexarotene
Sponsored by
Eisai Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring NSCLC, Targretin, Retinoid, Bexarotene

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brookwood Medical Center
  • Southern Arizona VA Healthcare System
  • Arroyo Research Inc.
  • Desert Hematology-Oncology Medical Group, Inc.
  • University of Florida
  • New Hope Cancer Center
  • Veterans Affairs Medical Center
  • Bay Area Cancer Consultants
  • Northwest Medical Specialists
  • Jayne Gurtler, M.D., APMC
  • Louisiana State University Health Science Center
  • St. Joseph Mercy Oakland Hospital
  • Capitol Comprehensive Cancer Care Clinic
  • SUNY Downstate Medical Center
  • VA Western New York Health Care System
  • Hematology-Oncology Associates
  • Tariq Mahmood
  • University Oncology & Hematology Associates
  • Marshfield Medical Research Foundation
  • Medical Associates Health Centers
  • Canberra Hospital
  • Port Macquarie Base Hospital
  • Southern Medical Daycare Centre
  • Burnside War Memorial Hospital
  • Queen Elizabeth Hospital
  • Royal Hobart Hospital
  • Box Hill Hospital
  • Border Medical Oncology
  • Tom Baker Cancer Centre
  • Cancer Care Manitoba
  • QEII Health Sciences Center
  • Ottawa Regional Cancer Centre
  • Nemocnice odd. Onkologie
  • Pneumologicka klinika 1. LF UK
  • Klinika pneumologie a hrudni chirurgie 3.LF
  • Centre Hospitalier General de Belfort
  • Centre Hospitalier Francois Maillot
  • Institut Jean Godinot
  • Centre Hospitalier Intercommunal de la Haute-Saone
  • University Hospital of Alexandroupolis
  • University General Hospital of Heraklion
  • 1st Pulmonary Clinic of G. Papanikolaou Hospital
  • 2nd Pulmonary Clinic of G. Papanikolaou Hospital
  • 6th Pneumonology Department, Sotiria Hospital for Diseases of the Chest
  • 7th Pneumonology Clinic, Sotiria Hospital for Diseases of the Chest
  • University Hospital of Patras
  • Semmelweis University Department of Pulmonology
  • Fovarosi Onkormanyzat Uzsoki utcai, Korhaza
  • Koranyi National Institute for Pulmonology
  • Csongrad Megyei Onkormanyzat Mellkasi
  • Barzilai Medical Centre
  • Hadassah Medical Center
  • Meir Hospital
  • Kaplan Medical Center
  • Tel-Aviv Sovrasky Medical Center
  • Sheba Medical Center
  • Assaf Harofeh Medical Center
  • Regionalne Centrum Onkologii
  • Akademii Medycznej w Gdansku
  • Centrum Onkologii Instytut im. M. Sklodowskiej-Curie
  • Wielkopolskie Centrum Chorob Pluc I Gruzlicy
  • Instytut Gruzlicy i Chorob Pluc
  • Arkhangelsk Regional Oncology Center
  • City Oncology Clinical Center
  • Russian Oncology Research Center n.a. Blokhin
  • Research Institute of Oncology n.a. Hertzen
  • Central Clinical Hospital n.a. Semashko
  • City Oncology Hospital #62
  • City Oncology Center
  • St. Petersburg Pavlov State Medical University
  • Research Institute of Oncology n.a. Petrov
  • Aberdeen Royal Infirmary
  • Bristol Hematology and Oncology Centre
  • Leicester Royal Infirmary
  • Guys & St. Thomas' Cancer Centre
  • Chelsea & Westminster Hospital
  • University of Edinburgh

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 31, 2002
Last Updated
May 13, 2013
Sponsor
Eisai Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00050973
Brief Title
Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-small Cell 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 Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
November 2004 (Actual)
Study Completion Date
March 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eisai Inc.

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
NSCLC, Targretin, Retinoid, Bexarotene

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
623 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
bexarotene

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mack Mabry, M.D.
Organizational Affiliation
Ligand Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Brookwood Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Southern Arizona VA Healthcare System
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
Arroyo Research Inc.
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Desert Hematology-Oncology Medical Group, Inc.
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
University of Florida
City
Gainsville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
New Hope Cancer Center
City
Hudson
State/Province
Florida
ZIP/Postal Code
34667
Country
United States
Facility Name
Veterans Affairs Medical Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Bay Area Cancer Consultants
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Northwest Medical Specialists
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60004
Country
United States
Facility Name
Jayne Gurtler, M.D., APMC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Louisiana State University Health Science Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
St. Joseph Mercy Oakland Hospital
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Facility Name
Capitol Comprehensive Cancer Care Clinic
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
VA Western New York Health Care System
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Hematology-Oncology Associates
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Tariq Mahmood
City
MIdwest City
State/Province
Oklahoma
ZIP/Postal Code
73110
Country
United States
Facility Name
University Oncology & Hematology Associates
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Marshfield Medical Research Foundation
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Medical Associates Health Centers
City
Menomonee Falls
State/Province
Wisconsin
ZIP/Postal Code
53051
Country
United States
Facility Name
Canberra Hospital
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Port Macquarie Base Hospital
City
Port Macquarie
State/Province
New South Wales
ZIP/Postal Code
2444
Country
Australia
Facility Name
Southern Medical Daycare Centre
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Burnside War Memorial Hospital
City
Toorak Gardens
State/Province
South Australia
ZIP/Postal Code
5065
Country
Australia
Facility Name
Queen Elizabeth Hospital
City
Woodville
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7001
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Border Medical Oncology
City
Wodonga
State/Province
Victoria
ZIP/Postal Code
3690
Country
Australia
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cancer Care Manitoba
City
Winnepeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
QEII Health Sciences Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Ottawa Regional Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1C4
Country
Canada
Facility Name
Nemocnice odd. Onkologie
City
Ceske Budejovice
ZIP/Postal Code
370 87
Country
Czech Republic
Facility Name
Pneumologicka klinika 1. LF UK
City
Praha-6-Veleslavin
ZIP/Postal Code
CZ-160 00
Country
Czech Republic
Facility Name
Klinika pneumologie a hrudni chirurgie 3.LF
City
Praha-8
ZIP/Postal Code
CZ-180 00
Country
Czech Republic
Facility Name
Centre Hospitalier General de Belfort
City
Belfort
State/Province
Cedex
ZIP/Postal Code
90016
Country
France
Facility Name
Centre Hospitalier Francois Maillot
City
Briey
State/Province
Cedex
ZIP/Postal Code
54150
Country
France
Facility Name
Institut Jean Godinot
City
Reims
State/Province
Cedex
ZIP/Postal Code
51100
Country
France
Facility Name
Centre Hospitalier Intercommunal de la Haute-Saone
City
Vesoul
State/Province
Cedex
ZIP/Postal Code
70014
Country
France
Facility Name
University Hospital of Alexandroupolis
City
Dragana
State/Province
Alexandroupolis
ZIP/Postal Code
68100
Country
Greece
Facility Name
University General Hospital of Heraklion
City
Heraklion
State/Province
Crete
Country
Greece
Facility Name
1st Pulmonary Clinic of G. Papanikolaou Hospital
City
Exochi
State/Province
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
2nd Pulmonary Clinic of G. Papanikolaou Hospital
City
Exochi
State/Province
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
6th Pneumonology Department, Sotiria Hospital for Diseases of the Chest
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
7th Pneumonology Clinic, Sotiria Hospital for Diseases of the Chest
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
University Hospital of Patras
City
Rio
ZIP/Postal Code
26500
Country
Greece
Facility Name
Semmelweis University Department of Pulmonology
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Fovarosi Onkormanyzat Uzsoki utcai, Korhaza
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Koranyi National Institute for Pulmonology
City
Budapest
ZIP/Postal Code
1529
Country
Hungary
Facility Name
Csongrad Megyei Onkormanyzat Mellkasi
City
Deszk
ZIP/Postal Code
6772
Country
Hungary
Facility Name
Barzilai Medical Centre
City
Ashkelon
ZIP/Postal Code
78308
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
19200
Country
Israel
Facility Name
Meir Hospital
City
Kfar Sava
ZIP/Postal Code
44281
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Tel-Aviv Sovrasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52620
Country
Israel
Facility Name
Assaf Harofeh Medical Center
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Regionalne Centrum Onkologii
City
Bialystok
ZIP/Postal Code
15-027
Country
Poland
Facility Name
Akademii Medycznej w Gdansku
City
Gdansk
ZIP/Postal Code
80-216
Country
Poland
Facility Name
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie
City
Krakow
ZIP/Postal Code
31-115
Country
Poland
Facility Name
Wielkopolskie Centrum Chorob Pluc I Gruzlicy
City
Poznan
ZIP/Postal Code
66-569
Country
Poland
Facility Name
Instytut Gruzlicy i Chorob Pluc
City
Warsaw
ZIP/Postal Code
01-138
Country
Poland
Facility Name
Arkhangelsk Regional Oncology Center
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
City Oncology Clinical Center
City
Moscow
ZIP/Postal Code
107005
Country
Russian Federation
Facility Name
Russian Oncology Research Center n.a. Blokhin
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Research Institute of Oncology n.a. Hertzen
City
Moscow
ZIP/Postal Code
12584
Country
Russian Federation
Facility Name
Central Clinical Hospital n.a. Semashko
City
Moscow
ZIP/Postal Code
129128
Country
Russian Federation
Facility Name
City Oncology Hospital #62
City
Moscow
ZIP/Postal Code
143423
Country
Russian Federation
Facility Name
City Oncology Center
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
St. Petersburg Pavlov State Medical University
City
St. Petersburg
ZIP/Postal Code
197089
Country
Russian Federation
Facility Name
Research Institute of Oncology n.a. Petrov
City
St. Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Aberdeen Royal Infirmary
City
Foresterhill
State/Province
Aberdeen
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Bristol Hematology and Oncology Centre
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Guys & St. Thomas' Cancer Centre
City
London
State/Province
England
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Chelsea & Westminster Hospital
City
London
State/Province
England
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
Facility Name
University of Edinburgh
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH4 2XU
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.Ligand.com
Description
Related Info

Learn more about this trial

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

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