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
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Eisai Inc. |
United States, Australia, Canada, Czech Republic, France, Greece, Hungary, Israel, Poland, Russian Federation, United Kingdom,
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