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.
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung
Both
Carcinoma, Non-Small-Cell Lung
Trial Information
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.
Inclusion 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Authority:
United States: Food and Drug Administration
Study ID:
BMS TAX/MEN.12
NCT ID:
NCT00035152
Start Date:
June 2000
Completion Date:
December 2004
Related Keywords:
- Carcinoma, Non-Small-Cell Lung
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
Name | Location |
|---|---|
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
| Community Medical Center | Toms River, New Jersey 08755 |
| Madigan Army Medical Center | Tacoma, Washington 98431-5048 |
| West Suburban Center for Cancer Care | River Forest, Illinois 60305 |
| Maimonides Medical Center | Brooklyn, New York 11219 |
| Creighton University Cancer Center | Omaha, Nebraska 68131-2197 |
| Southwest Regional Cancer Center | Austin, Texas 78705 |
| Good Samaritan Medical Center | West Palm Beach, Florida 33401 |
| Louisiana Oncology Associates | Lafayette, Louisiana 70506 |
| WellStar Cobb Hospital | Austell, Georgia 30106 |
| Mercy Cancer Center | Mason City, Iowa 50401 |
| Ellis Fischel Cancer Center | Columbia, Missouri 65203 |
| Highlands Oncology Group | Springdale, Arkansas 72764 |
| Genesis Cancer Center | Hot Springs, Arkansas 71913 |
| Medical Oncology Care Associates | Orange, California 92668 |
| Hennepin County Medical Center | Minneapolis, Minnesota |
| Maine General Medical Center | Waterville, Maine 04901 |
| Advanced Oncology Associates | Armonk, New York 10504 |
| New Mexico Oncology Hematology Consultants | Albuquerque, New Mexico 87102 |
| Little Rock Hematology/Oncology Associates | Little Rock, Arkansas 72205 |
| Naval Medical Center | San Diego, California 92134 |
| Danbury Hospital/Praxair Cancer Center | Danbury, Connecticut 06810 |
| Washington VA Medical Center | Washington, District of Columbia 20422 |
| Walter Reed Army Hospital | Washington, District of Columbia 20307 |
| Joliet Oncology/Hematology Associates,Ltd. | Joliet, Illinois 60435 |
| Mid Illinois Hematology and Oncology Associates, Ltd. | Normal, Illinois 61761 |
| Community Cancer Care, Inc. | Indianapolis, Indiana 46202 |
| Associated Physicians & Surgeons Clinic, LLC | Terre Haute, Indiana 47804 |
| Siouxland Hematology/Oncology Associates | Sioux City, Iowa 51101 |
| Jewish Medical Plaza | Louisville, Kentucky 40202 |
| University of Louisville | Louisville, Kentucky 40202 |
| Louisiana State University Health Sciences Center | Shreveport, Louisiana 71130 |
| Hematology and Oncology Associates of Southern Michigan,P.C | Jackson, Michigan 49201 |
| Fairview-University Medical Center, University of Minnesota | Minneapolis, Minnesota 55455 |
| Metro Minnesota CCOP | St. Louis Park, Minnesota 55416 |
| The Center for Cancer and Hematologic Disease | Cherry Hill, New Jersey 08003 |
| Hematology-Oncology of Central New Jersey | Red Bank, New Jersey 07701 |
| Brooklyn VA | Brooklyn, New York 11209 |
| Clifton Springs Hospital and Clinic | Clifton Springs, New York 14432 |
| Goshen Medical Associates | Goshen, New York 10924 |
| New York Oncology-Hematology,P.C./Capital District Hematology, Oncology Associates | Latham, New York 12110 |
| Hematology/Oncology of Rockland | New York, New York |
| Upstate New York Cancer R & E | Rochester, New York 14623 |
| Raleigh Hematology Associates, Wake Practice | Cary, North Carolina 27609 |
| Quadrangle Medical Specialists, Southern Oncology Research | Greenville, North Carolina 27834 |
| Mid Dakota Clinic | Bismarck, North Dakota 58501 |
| Columbus CCOP | Columbus, Ohio 43206 |
| Central Pennsylvania Hematology & Medical Oncology Associates, P.C. | Lemoyne, Pennsylvania 17043 |
| Albert Einstein Healthcare Network | Philadelphia, Pennsylvania 19141 |
| University of Pittsburgh Medical Center/University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
| Guthrie Clinic Ltd | Sayre, Pennsylvania 18840 |
| Boston Cancer Group, PLC | Memphis, Tennessee 38104 |
| Don & Sybil Harrington Cancer Center | Amarillo, Texas 79106 |
| Brackenridge Hospital | Austin, Texas 78701 |
| Southwest Cancer Center | Lubbock, Texas 79415 |
| Northwest Medical Specialties, PLLC | Tacoma, Washington 98405 |
