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

Condition(s) targeted: Non-Small Cell Lung Cancer

Intervention: Targretin capsules (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Eisai Medical Research Inc.

Official(s) and/or principal investigator(s):
Mack Mabry, M.D., Study Director, Affiliation: Ligand Pharmaceuticals

Ligand Pharmaceuticals Inc. is studying the use of Targretin capsules (bexarotene) in combination with standard chemotherapy for the treatment of metastatic non-small cell lung cancer in patients who have not yet received chemotherapy for their lung cancer.

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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Detailed description: Ligand Pharmaceuticals Inc. is studying the use of Targretin capsules (bexarotene) in combination with Carboplatin and Paclitaxel for the treatment of metastatic non-small cell lung cancer in patients who have not yet received chemotherapy for their lung cancer. In these studies, every patient receives a platinum-containing chemotherapy every three 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.

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

Kaiser-Franz-Josef-Spital, Wien A-1100, Austria

Allgemeines offentliches Krankenhaus der barmherzigen Schwestern vom Heiligen Kreuz Pneumologie, Wels 4600, Austria

Sozialmedizinisches Zentrum, Wien 1145, Austria

Centre Hospitalier General de la Region Annecienne, Annecy Cedex 47011, France

DOP International, Creteil 94010, France

Hopital Saint Anne, Toulon Naval 83800, France

Centre Hospitalier, Villefranche sur Soane 69655, France

CHU - Hopital Nord, St. Etienne, Cedex 2 42055, France

CHRU Hopital de Bois Guillaume, Bois Guillaume 76230, France

Centre Hospitalier du Pays d'Aix, Aix en Provence, Cedex 01 13616, France

Service de Pneumology, Hopital Adulte de Brabois, Vandoeuvre les Nancy 54511, France

Hopital Saint Antoine, Paris, Cedex 12 75571, France

Centre Hospitalier d'Antibes-Juan-Les-Pins, Antibes Cedex 06606, France

Hopital de Draguignan, Draguignan 83300, France

Centre Regional de Lutte contre le Cancer (CRLC), Val d'Aurelle-Paul Lamarque, Montpellier, Cedex 05 34298, France

Centre Hospitalier General, Gap Cedex 05007, France

Hopital du Cluzeau, Limoges Cedex 87042, France

CHU Hopital St. Marguerite, Marseille, Cedex 09 29274, France

Aesklepios-Fachkliniken Muchen-Gauting, Gauting D-82131, Germany

Krankenhaus GroBhansdorf, Zentrum fur Pneumologie und Thoraxchirurgie, GroBhansdorf 22927, Germany

Ludwig-Maximilians Universitat Munchen, Munchen 80336, Germany

Charite Universitatsklinikum der Humboldt-Universitat zu Berlin, SchumannstraBe, Berlin 10117, Germany

Dept. of Internal Medicine, St. Nikolaus-Stiftshospital Andernach, Andernach D-56626, Germany

Hospital Universitario Doctor Peset, Valencia 46 017, Spain

Hospital Clinico Universitario, Servicio Hematologia y Oncologia, Valencia 46044, Spain

Hospital de Sagunto Servicio de Oncologia, Valencia 46520, Spain

Hospital Arnau de Villanova, Servicio de Oncologia, Valencia 46039, Spain

Hospital Universitario La Fe Servicio de Oncologia, Valencia 46018, Spain

Hospital Clinico San Carlos, Madrid 28040, Spain

Hospital Provincial de Castellon, Castellon 12002, Spain

Montgomery Cancer Center, L.L.C., Montgomery, Alabama 36106, United States

Arizona Clinical Research Center, Inc., Tucson, Arizona 85712, United States

Sutter Gould Medical Foundation, Modesto, California 95355, United States

Sharp Health Care, San Diego, California 92123, United States

Sant P. Chawla, Inc., LOS ANGELES, California 90067, United States

California Cancer Care, Inc., Greenbrae, California 94909, United States

Compassionate Cancer Care Medical Group, Inc., Fountain Valley, California 92708, United States

Pacific Coast Hematology/Oncology Medical Group, Inc., Fountain Valley, California 92708, United States

Metropolitan Hematology/Oncology Medical Group, Los Angeles, California 90057, United States

Southern California Kaiser Permanente Medical Group, San Diego, California 92120, United States

Medical Group of North County, Inc., San Diego Cancer Center, Vista, California 92083, United States

Medical Oncology Care Associates, Orange, California 92868, United States

Bay Area Cancer Research Group, LLC, Concord, California 94520, United States

UCSF/Mount Zion Comprehensive Cancer Center, San Francisco, California 94115, United States

Coast Hematology and Oncology Associates, Long Beach, California 90806, United States

UCLA Medical Center, Los Angeles, California 94115, United States

Rocky Mountain Cancer Centers - Midtown, Denver, Colorado 80218, United States

Eastern Connecticut Hematology & Oncology, Norwich, Connecticut 06360, United States

Georgetown University Hospital, Washington, District of Columbia 20007, United States

Washington Cancer Institute, Washington, District of Columbia 20010, United States

Oncology and Radiation Associates, Miami, Florida 33133, United States

University of Florida/Jacksonville, Jacksonville, Florida 32209, United States

Florida Oncology Associates, Orange Park, Florida 32073, United States

Florida Cancer Institute, New Port Richey, Florida 34652, United States

Comprehensive Cancer Care Specialists of Boca Raton, Boca Raton, Florida 33428, United States

Watson Clinic, Lakeland, Florida 33805, United States

Cancer Centers of Florida, P.A., Orlando, Florida 32806, United States

South Florida Oncology & Hematology Consultants, Plantation, Florida 33324, United States

Medical Oncology Associates of Augusta, Augusta, Georgia 30901, United States

Georgia Oncology Partners Research & Education Foundation, Marietta, Georgia 30060, United States

St. Luke's/Mountain State Tumor Institute (MSTI), Boise, Idaho 83712, United States

Lutheran General Cancer Care Center, Park Ridge, Illinois 60068, United States

Northwest Oncology and Hematology, SC, Elk Grove Village, Illinois 60007, United States

Oncology/Hematology Associates of Central Illinois, P.C., Peoria, Illinois 61602, United States

Hematology Oncology Assoc. of Illinois, Skokie, Illinois 60077, United States

Weiss Memorial Hospital, Chicago, Illinois 60640, United States

Cancer Care Center, New Albany, Indiana 47150, United States

Michiana Hematology-Oncology, South Bend, Indiana 46601, United States

Central Indiana Cancer Centers, Indianapolis, Indiana 46227, United States

Kansas City Oncology and Hematology Group, Kansas City Cancer Centers, Overland Park, Kansas 66210, United States

Drs. Carroll, Sheth, and Raghavan, Louisville, Kentucky 40215, United States

APMC, Metairie, Louisiana 70006, United States

Southwest Oncology Associates, Lafayette, Louisiana 70503, United States

Louisiana State University Health Sciences Center, New Orleans, Louisiana 70112, United States

Tulane University Health Sciences Center, New Orleans, Louisiana 70112, United States

Chesapeake Oncology-Hematology Associates, Baltimore, Maryland 21225, United States

Mercy Medical Center, Baltimore, Maryland 21202, United States

Associates in Oncology/Hematology PC, Rockville, Maryland 20850, United States

Berkshire Hematology Oncology, PC, Pittsfield, Massachusetts 01201, United States

Providence Cancer Institute, Southfield, Michigan 48075, United States

University of Michigan Medical Center, Ann Arbor, Michigan 48109, United States

St. Lukes Hospital, Duluth, Minnesota 55805, United States

Minnesota Oncology Hematology, P.A., Minneapolis, Minnesota 55407, United States

Missouri Cancer Associates, Columbia, Missouri 65201, United States

Montana Cancer & Infectious Disease Specialists, Missoula, Montana 59802, United States

Hematology Oncology Centers of the Northern Rockies, Billings, Montana 59101, United States

Cancer and Blood Specialists of Nevada, Henderson, Nevada 89014, United States

Nevada Cancer Center, Las Vegas, Nevada 89109, United States

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire 03756, United States

Orange Medical Group, East Orange, New Jersey 07018, United States

VA New Jersey Health Care System, East Orange, New Jersey 07018, United States

Somerset Hematology Oncology Associates, Somerset, New Jersey 08873, United States

University of Medicine & Dentistry of NJ, School of Osteopathic Medicine, Stratford, New Jersey 08084, United States

Overlook Oncology Center, Summit, New Jersey 07901, United States

Hematology-Oncology Associates of Northern NJ, PA, Morristown, New Jersey 07962, United States

San Juan Oncology Associates, Farmington, New Mexico 87401, United States

Arena Oncology Associates, Great Neck, New York 11021, United States

Erie Medical Center, Buffalo, New York 14215, United States

New York Oncology Hematology, P.C., Capital District Hematology Oncology Associates, Albany, New York 12208, United States

Columbia Presbyterian Medical Center, New York, New York 10032, United States

New York Presbyterian Hospital, Weill Medical College of Cornell University, New York, New York 10021, United States

Roswell Park Cancer Institute, Buffalo, New York 14263, United States

Cancer Research of Long Island, Inc., Great Neck, New York 11023, United States

New York Oncology Hematology, P.C., Riverview Cancer Care Medical Associates, Rexford, New York 12148, United States

Cancer Institute of Long Island, Inc., Great Neck, New York 11023, United States

Broome Oncology, LLC, Johnson City, New York 13790, United States

VA Medical Center, Northport, New York 11768, United States

South Shore Hematology Oncology Associates, PC, Rockville Centre, New York 11570, United States

Northwest Carolina Oncology and Hematology, P.A., Hickory, North Carolina 28602, United States

Raleigh Hematology Oncology Clinic, Cary, North Carolina 27511, United States

Nashat Y. Gabrail, MD, Inc., Canton, Ohio 44718, United States

Dayton Oncology/Hematology Consultants, Dayton, Ohio 45439, United States

Columbus Community Clinical Oncology Program, Columbus, Ohio 43206, United States

University of Cincinnati, Barrett Cancer Center, Cincinnati, Ohio 45219, United States

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma 73104, United States

Cancer Care Associates - Mercy Campus, Oklahoma City, Oklahoma 73120, United States

Cancer Care Associates, Tulsa, Oklahoma 74136, United States

Algoma Regional Cancer Program - Sault Area Hospital, Sault Ste. Marie, Ontario P6A 2C4, Canada

Humber River Regional Hospital, Weston, Ontario M9N 1N8, Canada

Oncology/Hematology, Kaiser Permanente Northwest, Portland, Oregon 97227, United States

Oncology Hematology of Lehigh Valley, PC, Bethlehem, Pennsylvania 18015, United States

Medical Oncology Associates of Wyoming Valley, PC, Kingston, Pennsylvania 18704, United States

S.M.B.D. Jewish General Hospital, Montreal, Quebec H3T 1E2, Canada

Santee Hematology/Oncology, Sumter, South Carolina 29150, United States

WJB Dorn VA Medical Center, Columbia, South Carolina 29209, United States

Liberty Hematology/Oncology, Columbia, South Carolina 29203, United States

Cancer Centers of the Carolinas, Seneca, South Carolina 29672, United States

Charleston Hematology Oncology P.A., Charleston, South Carolina 29403, United States

Thompson Cancer Survival Center, Knoxville, Tennessee 37916, United States

Boston Baskin Cancer Group, Memphis, Tennessee 38104, United States

University of Texas, MD Anderson Cancer Center, Houston, Texas 77030, United States

Lone Star Oncology Consultants, P.A., Austin, Texas 78759, United States

Hope Oncology, Richardson, Texas 75080, United States

Hematology & Oncology Associates of South Texas, San Antonio, Texas 78229, United States

Cancer Specialists of South Texas, PA, Corpus Christi, Texas 78412, United States

Texas Oncology, P.A., Arlington, Texas 76012, United States

Texas Oncology, P.A., Dallas, Texas 75246, United States

South Austin Cancer Center, Austin, Texas 78745, United States

Texas Cancer Center at Medical City, Dallas, Texas 75230, United States

West Texas Cancer Center, Odessa, Texas 79761, United States

Texas Oncology, P.A., Garland, Texas 75042, United States

Tyler Cancer Center, Tyler, Texas 75702, United States

Texas Oncology, P.A., Fort Worth, Texas 76104, United States

Texoma Cancer Center, Wichita Falls, Texas 76310, United States

Allison Cancer Center, Midland, Texas 79701, United States

Utah Cancer Specialists, Salt Lake City, Utah 84106, United States

Danville Hematology & Oncology, Inc., Danville, Virginia 24541, United States

Virginia Cancer Institute, Richmond, Virginia 23230, United States

Arlington Fairfax Hematology Oncology, Arlington, Virginia 22205, United States

Stark MD, PC, Portsmouth, Virginia 23707, United States

Hematology Oncology Patient Enterprises, Center for Cancer Care, Charlottesville, Virginia 22902, United States

Virginia Oncology Associates, Norfolk, Virginia 23502, United States

Yakima Regional Cancer Care Center, Internal Medicine Associates of Yakima, Inc., Yakima, Washington 98902, United States

Morgantown Internal Medicine Group, Morgantown, West Virginia 26505, United States

Last updated: April 11, 2007