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:
Eisai Inc.
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00050973
First received: December 31, 2002
Last updated: May 13, 2013
Last verified: July 2008
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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) |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00050973
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Hide Study LocationsLocations
| 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 May 16, 2013