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/Carboplatin/Paclitaxel Versus Carboplatin/Paclitaxel in Chemotherapy-Naïve Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00050960
• Other study ID #: L1069-48
• Status: Completed
• Phase: Phase 3
• First received: December 31, 2002
• Last updated: July 7, 2012
• Start date: May 2002
• Est. completion date: March 2005

Study information

• 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

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 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. 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.

Other known NCT identifiers

• NCT00036907

Recruitment information / eligibility

• 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

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 with carboplatin and paclitaxel
bexarotene capsules (400 mg/m^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.
• carboplatin and paclitaxel
carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Countries where clinical trial is conducted

United States,  Austria,  Canada,  France,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		From date of randomization to date of death	No

External Links

•   Link