Study Comparing Weekly Taxol and Carboplatin vs Standard Taxol and Carboplatin Regimen for Stage IIIB or IV Non-Small-Cell Lung Cancer - Full Text View

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00035152

Purpose

Taxol and carboplatin are commonly used drugs for the treatment of stage IIIB or IV non small cell lung carcinoma.

This study compares treatment with Taxol/carboplatin given every 3 weeks to a schedule where it is given weekly.

The purpose of the study is to determine the most effective and safe schedule for giving these drugs in non small cell lung carcinoma.

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: Paclitaxel and carboplatin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Randomized Trial for Stage IIIB or IV NSCLC Comparing Weekly Taxol(Paclitaxel) and Carboplatin(Paraplatin) Regimen Versus Standard Taxol and Carboplatin Administered Every Three Weeks, Followed by Weekly Taxol.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Paclitaxel Carboplatin

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Estimated Enrollment:	444
Study Start Date:	June 2000
Estimated Study Completion Date:	December 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Confirmation of non-small cell bronchogenic carcinoma (epidermoid, squamous, adeno, large cell anaplastic carcinoma, but no small cell or carcinoid) must be histologically or cytologically confirmed.
No prior antineoplastic chemotherapy, hormonal therapy or therapy with biological response modifiers
No previous irradiation to the only area of measurable disease.

Exclusion Criteria:

Past or current history of neoplasm other than the entry diagnosis. Exceptions are curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or other cancers treated by surgery or radiation with a disease free survival longer than 5 years.
Patients who have undergone surgery less than 3 weeks prior to enrollment.
History of serious cardiac disease not adequately controlled.
Patients with serious active infections or other serious underlying medical condition.
Uncontrolled diabetes mellitis.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035152

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Locations

United States, Arkansas
Highlands Oncology Group
Springdale, Arkansas, United States, 72764
Genesis Cancer Center
Hot Springs, Arkansas, United States, 71913
Little Rock Hematology/Oncology Associates
Little Rock, Arkansas, United States, 72205
United States, California
Medical Oncology Care Associates
Orange, California, United States, 92868
Naval Medical Center
San Diego, California, United States, 92134
United States, Connecticut
Danbury Hospital/Praxair Cancer Center
Danbury, Connecticut, United States, 06810
United States, District of Columbia
Washington VA Medical Center
Washington, District of Columbia, United States, 20422
Walter Reed Army Hospital
Washington, District of Columbia, United States, 20307
United States, Florida
Good Samaritan Medical Center
West Palm Beach, Florida, United States, 33401
United States, Georgia
Wellstar Cobb Hospital
austell, Georgia, United States, 30060
United States, Illinois
Mid Illinois Hematology and Oncology Associates, Ltd.
Normal, Illinois, United States, 61761
Joliet Oncology/Hematology Associates,Ltd.
Joliet, Illinois, United States, 60435
West Suburban Center for Cancer Care
River Forest, Illinois, United States, 60305
United States, Indiana
Community Cancer Care, Inc.
Indianapolis, Indiana, United States, 46202
Associated Physicians & Surgeons Clinic, LLC
Terre Haute, Indiana, United States, 47804
United States, Iowa
Siouxland Hematology/Oncology Associates
Sioux City, Iowa, United States, 51101
Mercy Cancer Center
Mason City, Iowa, United States, 50401
United States, Kentucky
Jewish Medical Plaza
Louisville, Kentucky, United States, 40202
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Louisiana
Louisiana Oncology Associates
Lafayette, Louisiana, United States, 70506
Louisiana State University Health Sciences Center
Shreveport, Louisiana, United States, 71130
United States, Maine
Maine General Medical Center
Waterville, Maine, United States, 04901
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Hematology and Oncology Associates of Southern Michigan,P.C
Jackson, Michigan, United States, 49201
United States, Minnesota
Fairview-University Medical Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455
Metro Minnesota CCOP
St. Louis Park, Minnesota, United States, 55416
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
United States, Missouri
Ellis Fischel Cancer Center
Columbia, Missouri, United States, 65203
United States, Nebraska
Creighton University Cancer Center
Omaha, Nebraska, United States, 68131
United States, New Jersey
Hematology-Oncology of Central New Jersey
Red Bank, New Jersey, United States, 07701
Community Medical Center
Toms River, New Jersey, United States, 08755
The Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, United States, 08003
United States, New Mexico
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, United States, 87109
United States, New York
Clifton Springs Hospital and Clinic
Clifton Springs, New York, United States, 14432
New York Oncology-Hematology,P.C./Capital District Hematology, Oncology Associates
Latham, New York, United States, 12110
Goshen Medical Associates
Goshen, New York, United States, 10924
Maimonides Medical Center
Brooklyn, New York, United States, 11209
Advanced Oncology Associates
Armonk, New York, United States, 10504
Brooklyn VA
Brooklyn, New York, United States, 11209
Upstate New York Cancer R & E
Rochester, New York, United States, 14623
Hematology/Oncology of Rockland
New York, New York, United States
United States, North Carolina
Quadrangle Medical Specialists, Southern Oncology Research
Greenville, North Carolina, United States, 27834
Raleigh Hematology Associates, Wake Practice
Cary, North Carolina, United States, 27609
United States, North Dakota
Mid Dakota Clinic
Bismarck, North Dakota, United States, 58501
United States, Ohio
Columbus CCOP
Columbus, Ohio, United States, 43206
United States, Pennsylvania
Central Pennsylvania Hematology & Medical Oncology Associates, P.C.
Lemoyne, Pennsylvania, United States, 17043
Guthrie Clinic Ltd
Sayre, Pennsylvania, United States, 18840
University of Pittsburgh Medical Center/University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, United States, 19141
United States, Tennessee
Boston Cancer Group, PLC
Memphis, Tennessee, United States, 38104
United States, Texas
Brackenridge Hospital
Austin, Texas, United States, 78701
Don & Sybil Harrington Cancer Center
Amarillo, Texas, United States, 79106
Southwest Cancer Center
Lubbock, Texas, United States, 79415
Southwest Regional Cancer Center
Austin, Texas, United States, 78705
United States, Washington
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States, 98405
Madigan Army Medical Center
Tacoma, Washington, United States, 98431

Sponsors and Collaborators

Bristol-Myers Squibb

More Information

Additional Information:

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	BMS TAX/MEN.12
Study First Received:	May 2, 2002
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00035152 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Antimitotic Agents
Carboplatin
Pharmacologic Actions
Carcinoma
Neoplasms

Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Paclitaxel
Therapeutic Uses
Lung Diseases
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 25, 2009