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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00050973
• Other study ID #: L1069-49
• Status: Completed
• Phase: Phase 3
• First received: December 31, 2002
• Last updated: May 13, 2013
• Est. completion date: March 2005

Study information

• Verified date: July 2008
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00030927

Recruitment information / eligibility

• Status: Completed
• Enrollment: 623
• Est. completion date: March 2005
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• bexarotene

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Czech Republic,  France,  Greece,  Hungary,  Israel,  Poland,  Russian Federation,  United Kingdom, 

External Links

•   Link