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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
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung

Thank you

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 CenterBoston, Massachusetts  02215
Community Medical CenterToms River, New Jersey  08755
Madigan Army Medical CenterTacoma, Washington  98431-5048
West Suburban Center for Cancer CareRiver Forest, Illinois  60305
Maimonides Medical CenterBrooklyn, New York  11219
Creighton University Cancer CenterOmaha, Nebraska  68131-2197
Southwest Regional Cancer CenterAustin, Texas  78705
Good Samaritan Medical CenterWest Palm Beach, Florida  33401
Louisiana Oncology AssociatesLafayette, Louisiana  70506
WellStar Cobb HospitalAustell, Georgia  30106
Mercy Cancer CenterMason City, Iowa  50401
Ellis Fischel Cancer CenterColumbia, Missouri  65203
Highlands Oncology GroupSpringdale, Arkansas  72764
Genesis Cancer CenterHot Springs, Arkansas  71913
Medical Oncology Care AssociatesOrange, California  92668
Hennepin County Medical CenterMinneapolis, Minnesota  
Maine General Medical CenterWaterville, Maine  04901
Advanced Oncology AssociatesArmonk, New York  10504
New Mexico Oncology Hematology ConsultantsAlbuquerque, New Mexico  87102
Little Rock Hematology/Oncology AssociatesLittle Rock, Arkansas  72205
Naval Medical CenterSan Diego, California  92134
Danbury Hospital/Praxair Cancer CenterDanbury, Connecticut  06810
Washington VA Medical CenterWashington, District of Columbia  20422
Walter Reed Army HospitalWashington, 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, LLCTerre Haute, Indiana  47804
Siouxland Hematology/Oncology AssociatesSioux City, Iowa  51101
Jewish Medical PlazaLouisville, Kentucky  40202
University of LouisvilleLouisville, Kentucky  40202
Louisiana State University Health Sciences CenterShreveport, Louisiana  71130
Hematology and Oncology Associates of Southern Michigan,P.CJackson, Michigan  49201
Fairview-University Medical Center, University of MinnesotaMinneapolis, Minnesota  55455
Metro Minnesota CCOPSt. Louis Park, Minnesota  55416
The Center for Cancer and Hematologic DiseaseCherry Hill, New Jersey  08003
Hematology-Oncology of Central New JerseyRed Bank, New Jersey  07701
Brooklyn VABrooklyn, New York  11209
Clifton Springs Hospital and ClinicClifton Springs, New York  14432
Goshen Medical AssociatesGoshen, New York  10924
New York Oncology-Hematology,P.C./Capital District Hematology, Oncology AssociatesLatham, New York  12110
Hematology/Oncology of RocklandNew York, New York  
Upstate New York Cancer R & ERochester, New York  14623
Raleigh Hematology Associates, Wake PracticeCary, North Carolina  27609
Quadrangle Medical Specialists, Southern Oncology ResearchGreenville, North Carolina  27834
Mid Dakota ClinicBismarck, North Dakota  58501
Columbus CCOPColumbus, Ohio  43206
Central Pennsylvania Hematology & Medical Oncology Associates, P.C.Lemoyne, Pennsylvania  17043
Albert Einstein Healthcare NetworkPhiladelphia, Pennsylvania  19141
University of Pittsburgh Medical Center/University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
Guthrie Clinic LtdSayre, Pennsylvania  18840
Boston Cancer Group, PLCMemphis, Tennessee  38104
Don & Sybil Harrington Cancer CenterAmarillo, Texas  79106
Brackenridge HospitalAustin, Texas  78701
Southwest Cancer CenterLubbock, Texas  79415
Northwest Medical Specialties, PLLCTacoma, Washington  98405