Clinical trial NCT00050973: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer
Keywords: NSCLC
Targretin
Retinoid
Bexarotene
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2003-01-03
Enrollment: 623
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Brookwood Medical Center
state: Alabama
city: Tucson
country: United States
facility: Southern Arizona VA Healthcare System
state: Arizona
city: Pasadena
country: United States
facility: Arroyo Research Inc.
state: California
city: Rancho Mirage
country: United States
facility: Desert Hematology-Oncology Medical Group, Inc.
state: California
city: Gainsville
country: United States
facility: University of Florida
state: Florida
city: Hudson
country: United States
facility: New Hope Cancer Center
state: Florida
city: Miami
country: United States
facility: Veterans Affairs Medical Center
state: Florida
city: Palm Harbor
country: United States
facility: Bay Area Cancer Consultants
state: Florida
city: Arlington Heights
country: United States
facility: Northwest Medical Specialists
state: Illinois
city: Metairie
country: United States
facility: Jayne Gurtler, M.D., APMC
state: Louisiana
city: New Orleans
country: United States
facility: Louisiana State University Health Science Center
state: Louisiana
city: Pontiac
country: United States
facility: St. Joseph Mercy Oakland Hospital
state: Michigan
city: Jefferson City
country: United States
facility: Capitol Comprehensive Cancer Care Clinic
state: Missouri
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
city: Buffalo
country: United States
facility: VA Western New York Health Care System
state: New York
city: Toledo
country: United States
facility: Hematology-Oncology Associates
state: Ohio
city: MIdwest City
country: United States
facility: Tariq Mahmood
state: Oklahoma
city: Chattanooga
country: United States
facility: University Oncology & Hematology Associates
state: Tennessee
city: Marshfield
country: United States
facility: Marshfield Medical Research Foundation
state: Wisconsin
city: Menomonee Falls
country: United States
facility: Medical Associates Health Centers
state: Wisconsin
city: Garran
country: Australia
facility: Canberra Hospital
state: Australian Capital Territory
city: Port Macquarie
country: Australia
facility: Port Macquarie Base Hospital
state: New South Wales
city: Wollongong
country: Australia
facility: Southern Medical Daycare Centre
state: New South Wales
city: Toorak Gardens
country: Australia
facility: Burnside War Memorial Hospital
state: South Australia
city: Woodville
country: Australia
facility: Queen Elizabeth Hospital
state: South Australia
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Wodonga
country: Australia
facility: Border Medical Oncology
state: Victoria
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Winnepeg
country: Canada
facility: Cancer Care Manitoba
state: Manitoba
city: Halifax
country: Canada
facility: QEII Health Sciences Center
state: Nova Scotia
city: Ottawa
country: Canada
facility: Ottawa Regional Cancer Centre
state: Ontario
city: Ceske Budejovice
country: Czech Republic
facility: Nemocnice odd. Onkologie
city: Praha-6-Veleslavin
country: Czech Republic
facility: Pneumologicka klinika 1. LF UK
city: Praha-8
country: Czech Republic
facility: Klinika pneumologie a hrudni chirurgie 3.LF
city: Belfort
country: France
facility: Centre Hospitalier General de Belfort
state: Cedex
city: Briey
country: France
facility: Centre Hospitalier Francois Maillot
state: Cedex
city: Reims
country: France
facility: Institut Jean Godinot
state: Cedex
city: Vesoul
country: France
facility: Centre Hospitalier Intercommunal de la Haute-Saone
state: Cedex
city: Dragana
country: Greece
facility: University Hospital of Alexandroupolis
state: Alexandroupolis
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion
state: Crete
city: Exochi
country: Greece
facility: 1st Pulmonary Clinic of G. Papanikolaou Hospital
state: Thessaloniki
city: Exochi
country: Greece
facility: 2nd Pulmonary Clinic of G. Papanikolaou Hospital
state: Thessaloniki
city: Athens
country: Greece
facility: 6th Pneumonology Department, Sotiria Hospital for Diseases of the Chest
city: Athens
country: Greece
facility: 7th Pneumonology Clinic, Sotiria Hospital for Diseases of the Chest
city: Rio
country: Greece
facility: University Hospital of Patras
city: Budapest
country: Hungary
facility: Semmelweis University Department of Pulmonology
city: Budapest
country: Hungary
facility: Fovarosi Onkormanyzat Uzsoki utcai, Korhaza
city: Budapest
country: Hungary
facility: Koranyi National Institute for Pulmonology
city: Deszk
country: Hungary
facility: Csongrad Megyei Onkormanyzat Mellkasi
city: Ashkelon
country: Israel
facility: Barzilai Medical Centre
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Kfar Sava
country: Israel
facility: Meir Hospital
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Tel-Aviv Sovrasky Medical Center
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Center
city: Bialystok
country: Poland
facility: Regionalne Centrum Onkologii
city: Gdansk
country: Poland
facility: Akademii Medycznej w Gdansku
city: Krakow
country: Poland
facility: Centrum Onkologii Instytut im. M. Sklodowskiej-Curie
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Chorob Pluc I Gruzlicy
city: Warsaw
country: Poland
facility: Instytut Gruzlicy i Chorob Pluc
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Regional Oncology Center
city: Moscow
country: Russian Federation
facility: City Oncology Clinical Center
city: Moscow
country: Russian Federation
facility: Russian Oncology Research Center n.a. Blokhin
city: Moscow
country: Russian Federation
facility: Research Institute of Oncology n.a. Hertzen
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital n.a. Semashko
city: Moscow
country: Russian Federation
facility: City Oncology Hospital #62
city: St. Petersburg
country: Russian Federation
facility: City Oncology Center
city: St. Petersburg
country: Russian Federation
facility: St. Petersburg Pavlov State Medical University
city: St. Petersburg
country: Russian Federation
facility: Research Institute of Oncology n.a. Petrov
city: Foresterhill
country: United Kingdom
facility: Aberdeen Royal Infirmary
state: Aberdeen
city: Bristol
country: United Kingdom
facility: Bristol Hematology and Oncology Centre
state: England
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
state: England
city: London
country: United Kingdom
facility: Guys & St. Thomas' Cancer Centre
state: England
city: London
country: United Kingdom
facility: Chelsea & Westminster Hospital
state: England
city: Edinburgh
country: United Kingdom
facility: University of Edinburgh
state: Scotland
Study officials:
affiliation: Ligand Pharmaceuticals
name: Mack Mabry, M.D.
role: STUDY_DIRECTOR
References: