Non-small Cell Lung Cancer Clinical Trial
Official title:
Randomized Phase III Trial Comparing Targretin Capsules/Carboplatin/Paclitaxel Versus Carboplatin/Paclitaxel in Chemotherapy-Naïve Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
Verified date | July 2012 |
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 | 612 |
Est. completion date | March 2005 |
Est. primary completion date | July 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 |
---|---|---|---|
Austria | Allgemeines offentliches Krankenhaus der barmherzigen Schwestern vom Heiligen Kreuz Pneumologie | Wels | |
Austria | Kaiser-Franz-Josef-Spital | Wien | |
Austria | Sozialmedizinisches Zentrum | Wien | |
Canada | S.M.B.D. Jewish General Hospital | Montreal | Quebec |
Canada | Algoma Regional Cancer Program - Sault Area Hospital | Sault Ste. Marie | Ontario |
Canada | Humber River Regional Hospital | Weston | Ontario |
France | Centre Hospitalier du Pays d'Aix | Aix en Provence, Cedex 01 | |
France | Centre Hospitalier General de la Region Annecienne | Annecy Cedex | |
France | Centre Hospitalier d'Antibes-Juan-Les-Pins | Antibes Cedex | |
France | CHRU Hopital de Bois Guillaume | Bois Guillaume | |
France | DOP International | Creteil | |
France | Hopital de Draguignan | Draguignan | |
France | Centre Hospitalier General | Gap Cedex | |
France | Hopital du Cluzeau | Limoges Cedex | |
France | CHU Hopital St. Marguerite | Marseille, Cedex 09 | |
France | Centre Regional de Lutte contre le Cancer (CRLC), Val d'Aurelle-Paul Lamarque | Montpellier, Cedex 05 | |
France | Hopital Saint Antoine | Paris, Cedex 12 | |
France | CHU - Hopital Nord | St. Etienne, Cedex 2 | |
France | Hopital Saint Anne | Toulon Naval | |
France | Service de Pneumology, Hopital Adulte de Brabois | Vandoeuvre les Nancy | |
France | Centre Hospitalier | Villefranche sur Soane | |
Germany | Dept. of Internal Medicine, St. Nikolaus-Stiftshospital Andernach | Andernach | |
Germany | Aesklepios-Fachkliniken Muchen-Gauting | Gauting | |
Germany | Krankenhaus GroBhansdorf, Zentrum fur Pneumologie und Thoraxchirurgie | GroBhansdorf | |
Germany | Ludwig-Maximilians Universitat Munchen | Munchen | |
Germany | Charite Universitatsklinikum der Humboldt-Universitat zu Berlin | SchumannstraBe, Berlin | |
Spain | Hospital Provincial de Castellon | Castellon | |
Spain | Hospital Clinico San Carlos | Madrid | |
Spain | Hospital Arnau de Villanova, Servicio de Oncologia | Valencia | |
Spain | Hospital Clinico Universitario, Servicio Hematologia y Oncologia | Valencia | |
Spain | Hospital de Sagunto Servicio de Oncologia | Valencia | |
Spain | Hospital Universitario Doctor Peset | Valencia | |
Spain | Hospital Universitario La Fe Servicio de Oncologia | Valencia | |
United States | New York Oncology Hematology, P.C., Capital District Hematology Oncology Associates | Albany | New York |
United States | University of Michigan Medical Center | Ann Arbor | Michigan |
United States | Arlington Fairfax Hematology Oncology | Arlington | Virginia |
United States | Texas Oncology, P.A. | Arlington | Texas |
United States | Medical Oncology Associates of Augusta | Augusta | Georgia |
United States | Lone Star Oncology Consultants, P.A. | Austin | Texas |
United States | South Austin Cancer Center | Austin | Texas |
United States | Chesapeake Oncology-Hematology Associates | Baltimore | Maryland |
United States | Mercy Medical Center | Baltimore | Maryland |
United States | Oncology Hematology of Lehigh Valley, PC | Bethlehem | Pennsylvania |
United States | Hematology Oncology Centers of the Northern Rockies | Billings | Montana |
United States | Comprehensive Cancer Care Specialists of Boca Raton | Boca Raton | Florida |
United States | St. Luke's/Mountain State Tumor Institute (MSTI) | Boise | Idaho |
United States | Erie Medical Center | Buffalo | New York |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | Nashat Y. Gabrail, MD, Inc. | Canton | Ohio |
United States | Raleigh Hematology Oncology Clinic | Cary | North Carolina |
United States | Charleston Hematology Oncology P.A. | Charleston | South Carolina |
United States | Hematology Oncology Patient Enterprises, Center for Cancer Care | Charlottesville | Virginia |
United States | Weiss Memorial Hospital | Chicago | Illinois |
United States | University of Cincinnati, Barrett Cancer Center | Cincinnati | Ohio |
United States | Liberty Hematology/Oncology | Columbia | South Carolina |
United States | Missouri Cancer Associates | Columbia | Missouri |
United States | WJB Dorn VA Medical Center | Columbia | South Carolina |
United States | Columbus Community Clinical Oncology Program | Columbus | Ohio |
United States | Bay Area Cancer Research Group, LLC | Concord | California |
United States | Cancer Specialists of South Texas, PA | Corpus Christi | Texas |
United States | Texas Cancer Center at Medical City | Dallas | Texas |
United States | Texas Oncology, P.A. | Dallas | Texas |
United States | Danville Hematology & Oncology, Inc. | Danville | Virginia |
United States | Dayton Oncology/Hematology Consultants | Dayton | Ohio |
United States | Rocky Mountain Cancer Centers - Midtown | Denver | Colorado |
United States | St. Lukes Hospital | Duluth | Minnesota |
United States | Orange Medical Group | East Orange | New Jersey |
United States | VA New Jersey Health Care System | East Orange | New Jersey |
United States | Northwest Oncology and Hematology, SC | Elk Grove Village | Illinois |
United States | San Juan Oncology Associates | Farmington | New Mexico |
United States | Texas Oncology, P.A. | Fort Worth | Texas |
United States | Compassionate Cancer Care Medical Group, Inc. | Fountain Valley | California |
United States | Pacific Coast Hematology/Oncology Medical Group, Inc. | Fountain Valley | California |
United States | Texas Oncology, P.A. | Garland | Texas |
United States | Arena Oncology Associates | Great Neck | New York |
United States | Cancer Institute of Long Island, Inc. | Great Neck | New York |
United States | Cancer Research of Long Island, Inc. | Great Neck | New York |
United States | California Cancer Care, Inc. | Greenbrae | California |
United States | Cancer and Blood Specialists of Nevada | Henderson | Nevada |
United States | Northwest Carolina Oncology and Hematology, P.A. | Hickory | North Carolina |
United States | University of Texas, MD Anderson Cancer Center | Houston | Texas |
United States | Central Indiana Cancer Centers | Indianapolis | Indiana |
United States | University of Florida/Jacksonville | Jacksonville | Florida |
United States | Broome Oncology, LLC | Johnson City | New York |
United States | Medical Oncology Associates of Wyoming Valley, PC | Kingston | Pennsylvania |
United States | Thompson Cancer Survival Center | Knoxville | Tennessee |
United States | Southwest Oncology Associates | Lafayette | Louisiana |
United States | Watson Clinic | Lakeland | Florida |
United States | Nevada Cancer Center | Las Vegas | Nevada |
United States | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire |
United States | Coast Hematology and Oncology Associates | Long Beach | California |
United States | Metropolitan Hematology/Oncology Medical Group | Los Angeles | California |
United States | Sant P. Chawla, Inc. | Los Angeles | California |
United States | UCLA Medical Center | Los Angeles | California |
United States | Drs. Carroll, Sheth, and Raghavan | Louisville | Kentucky |
United States | Georgia Oncology Partners Research & Education Foundation | Marietta | Georgia |
United States | Boston Baskin Cancer Group | Memphis | Tennessee |
United States | APMC | Metairie | Louisiana |
United States | Oncology and Radiation Associates | Miami | Florida |
United States | Allison Cancer Center | Midland | Texas |
United States | Minnesota Oncology Hematology, P.A. | Minneapolis | Minnesota |
United States | Montana Cancer & Infectious Disease Specialists | Missoula | Montana |
United States | Sutter Gould Medical Foundation | Modesto | California |
United States | Montgomery Cancer Center, L.L.C. | Montgomery | Alabama |
United States | Morgantown Internal Medicine Group | Morgantown | West Virginia |
United States | Hematology-Oncology Associates of Northern NJ, PA | Morristown | New Jersey |
United States | Cancer Care Center | New Albany | Indiana |
United States | Louisiana State University Health Sciences Center | New Orleans | Louisiana |
United States | Tulane University Health Sciences Center | New Orleans | Louisiana |
United States | Florida Cancer Institute | New Port Richey | Florida |
United States | Columbia Presbyterian Medical Center | New York | New York |
United States | New York Presbyterian Hospital, Weill Medical College of Cornell University | New York | New York |
United States | Virginia Oncology Associates | Norfolk | Virginia |
United States | VA Medical Center | Northport | New York |
United States | Eastern Connecticut Hematology & Oncology | Norwich | Connecticut |
United States | West Texas Cancer Center | Odessa | Texas |
United States | Cancer Care Associates - Mercy Campus | Oklahoma City | Oklahoma |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | Medical Oncology Care Associates | Orange | California |
United States | Florida Oncology Associates | Orange Park | Florida |
United States | Cancer Centers of Florida, P.A. | Orlando | Florida |
United States | Kansas City Oncology and Hematology Group, Kansas City Cancer Centers | Overland Park | Kansas |
United States | Lutheran General Cancer Care Center | Park Ridge | Illinois |
United States | Oncology/Hematology Associates of Central Illinois, P.C. | Peoria | Illinois |
United States | Berkshire Hematology Oncology, PC | Pittsfield | Massachusetts |
United States | South Florida Oncology & Hematology Consultants | Plantation | Florida |
United States | Oncology/Hematology, Kaiser Permanente Northwest | Portland | Oregon |
United States | Stark MD, PC | Portsmouth | Virginia |
United States | New York Oncology Hematology, P.C., Riverview Cancer Care Medical Associates | Rexford | New York |
United States | Hope Oncology | Richardson | Texas |
United States | Virginia Cancer Institute | Richmond | Virginia |
United States | Associates in Oncology/Hematology PC | Rockville | Maryland |
United States | South Shore Hematology Oncology Associates, PC | Rockville Centre | New York |
United States | Utah Cancer Specialists | Salt Lake City | Utah |
United States | Hematology & Oncology Associates of South Texas | San Antonio | Texas |
United States | Sharp Health Care | San Diego | California |
United States | Southern California Kaiser Permanente Medical Group | San Diego | California |
United States | UCSF/Mount Zion Comprehensive Cancer Center | San Francisco | California |
United States | Cancer Centers of the Carolinas | Seneca | South Carolina |
United States | Hematology Oncology Assoc. of Illinois | Skokie | Illinois |
United States | Somerset Hematology Oncology Associates | Somerset | New Jersey |
United States | Michiana Hematology-Oncology | South Bend | Indiana |
United States | Providence Cancer Institute | Southfield | Michigan |
United States | University of Medicine & Dentistry of NJ, School of Osteopathic Medicine | Stratford | New Jersey |
United States | Overlook Oncology Center | Summit | New Jersey |
United States | Santee Hematology/Oncology | Sumter | South Carolina |
United States | Arizona Clinical Research Center, Inc. | Tucson | Arizona |
United States | Cancer Care Associates | Tulsa | Oklahoma |
United States | Tyler Cancer Center | Tyler | Texas |
United States | Medical Group of North County, Inc., San Diego Cancer Center | Vista | California |
United States | Georgetown University Hospital | Washington | District of Columbia |
United States | Washington Cancer Institute | Washington | District of Columbia |
United States | Texoma Cancer Center | Wichita Falls | Texas |
United States | Yakima Regional Cancer Care Center, Internal Medicine Associates of Yakima, Inc. | Yakima | Washington |
Lead Sponsor | Collaborator |
---|---|
Eisai Inc. |
United States, Austria, Canada, France, Germany, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival | From date of randomization to date of death | No |
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