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

Condition(s) targeted: Carcinoma, Non-Small-Cell Lung

Intervention: Paclitaxel and carboplatin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bristol-Myers Squibb

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.

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.

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Highlands Oncology Group, Springdale, Arkansas 72764, United States

Genesis Cancer Center, Hot Springs, Arkansas 71913, United States

Little Rock Hematology/Oncology Associates, Little Rock, Arkansas 72205, United States

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

Naval Medical Center, San Diego, California 92134, United States

Danbury Hospital/Praxair Cancer Center, Danbury, Connecticut 06810, United States

Washington VA Medical Center, Washington, District of Columbia 20422, United States

Walter Reed Army Hospital, Washington, District of Columbia 20307, United States

Good Samaritan Medical Center, West Palm Beach, Florida 33401, United States

Wellstar Cobb Hospital, austell, Georgia 30060, United States

Mid Illinois Hematology and Oncology Associates, Ltd., Normal, Illinois 61761, United States

Joliet Oncology/Hematology Associates,Ltd., Joliet, Illinois 60435, United States

West Suburban Center for Cancer Care, River Forest, Illinois 60305, United States

Community Cancer Care, Inc., Indianapolis, Indiana 46202, United States

Associated Physicians & Surgeons Clinic, LLC, Terre Haute, Indiana 47804, United States

Siouxland Hematology/Oncology Associates, Sioux City, Iowa 51101, United States

Mercy Cancer Center, Mason City, Iowa 50401, United States

Jewish Medical Plaza, Louisville, Kentucky 40202, United States

University of Louisville, Louisville, Kentucky 40202, United States

Louisiana Oncology Associates, Lafayette, Louisiana 70506, United States

Louisiana State University Health Sciences Center, Shreveport, Louisiana 71130, United States

Maine General Medical Center, Waterville, Maine 04901, United States

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States

Hematology and Oncology Associates of Southern Michigan,P.C, Jackson, Michigan 49201, United States

Fairview-University Medical Center, University of Minnesota, Minneapolis, Minnesota 55455, United States

Metro Minnesota CCOP, St. Louis Park, Minnesota 55416, United States

Hennepin County Medical Center, Minneapolis, Minnesota 55415, United States

Ellis Fischel Cancer Center, Columbia, Missouri 65203, United States

Creighton University Cancer Center, Omaha, Nebraska 68131, United States

Hematology-Oncology of Central New Jersey, Red Bank, New Jersey 07701, United States

Community Medical Center, Toms River, New Jersey 08755, United States

The Center for Cancer and Hematologic Disease, Cherry Hill, New Jersey 08003, United States

New Mexico Oncology Hematology Consultants, Albuquerque, New Mexico 87109, United States

Clifton Springs Hospital and Clinic, Clifton Springs, New York 14432, United States

New York Oncology-Hematology,P.C./Capital District Hematology, Oncology Associates, Latham, New York 12110, United States

Goshen Medical Associates, Goshen, New York 10924, United States

Maimonides Medical Center, Brooklyn, New York 11209, United States

Advanced Oncology Associates, Armonk, New York 10504, United States

Brooklyn VA, Brooklyn, New York 11209, United States

Upstate New York Cancer R & E, Rochester, New York 14623, United States

Hematology/Oncology of Rockland, New York, New York, United States

Quadrangle Medical Specialists, Southern Oncology Research, Greenville, North Carolina 27834, United States

Raleigh Hematology Associates, Wake Practice, Cary, North Carolina 27609, United States

Mid Dakota Clinic, Bismarck, North Dakota 58501, United States

Columbus CCOP, Columbus, Ohio 43206, United States

Central Pennsylvania Hematology & Medical Oncology Associates, P.C., Lemoyne, Pennsylvania 17043, United States

Albert Einstein Healthcare Network, Philadelphia, Pennsylvania 19141, United States

University of Pittsburgh Medical Center/University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania 15213, United States

Guthrie Clinic Ltd, Sayre, Pennsylvania 18840, United States

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

Brackenridge Hospital, Austin, Texas 78701, United States

Don & Sybil Harrington Cancer Center, Amarillo, Texas 79106, United States

Southwest Cancer Center, Lubbock, Texas 79415, United States

Southwest Regional Cancer Center, Austin, Texas 78705, United States

Northwest Medical Specialties, PLLC, Tacoma, Washington 98405, United States

Madigan Army Medical Center, Tacoma, Washington 98431, United States

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

Starting date: June 2000
Ending date: December 2004
Last updated: August 23, 2007