Clinical trial NCT00035152: Study Comparing Weekly Taxol and Carboplatin vs Standard Taxol and Carboplatin Regimen for Stage IIIB or IV Non-Small-Cell Lung Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2002-05-03
Enrollment: 444
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Genesis Cancer Center
state: Arkansas
city: Little Rock
country: United States
facility: Little Rock Hematology/Oncology Associates
state: Arkansas
city: Springdale
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Orange
country: United States
facility: Medical Oncology Care Associates
state: California
city: San Diego
country: United States
facility: Naval Medical Center
state: California
city: Danbury
country: United States
facility: Danbury Hospital/Praxair Cancer Center
state: Connecticut
city: Washington
country: United States
facility: Walter Reed Army Hospital
state: District of Columbia
city: Washington
country: United States
facility: Washington VA Medical Center
state: District of Columbia
city: West Palm Beach
country: United States
facility: Good Samaritan Medical Center
state: Florida
city: Austell
country: United States
facility: Wellstar Cobb Hospital
state: Georgia
city: Joliet
country: United States
facility: Joliet Oncology/Hematology Associates,Ltd.
state: Illinois
city: Normal
country: United States
facility: Mid Illinois Hematology and Oncology Associates, Ltd.
state: Illinois
city: River Forest
country: United States
facility: West Suburban Center for Cancer Care
state: Illinois
city: Indianapolis
country: United States
facility: Community Cancer Care, Inc.
state: Indiana
city: Terre Haute
country: United States
facility: Associated Physicians & Surgeons Clinic, LLC
state: Indiana
city: Mason City
country: United States
facility: Mercy Cancer Center
state: Iowa
city: Sioux City
country: United States
facility: Siouxland Hematology/Oncology Associates
state: Iowa
city: Louisville
country: United States
facility: Jewish Medical Plaza
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Lafayette
country: United States
facility: Louisiana Oncology Associates
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana State University Health Sciences Center
state: Louisiana
city: Waterville
country: United States
facility: Maine General Medical Center
state: Maine
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Jackson
country: United States
facility: Hematology and Oncology Associates of Southern Michigan,P.C
state: Michigan
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Minneapolis
country: United States
facility: Fairview-University Medical Center, University of Minnesota
state: Minnesota
city: St. Louis Park
country: United States
facility: Metro Minnesota CCOP
state: Minnesota
city: Columbia
country: United States
facility: Ellis Fischel Cancer Center
state: Missouri
city: Omaha
country: United States
facility: Creighton University Cancer Center
state: Nebraska
city: Cherry Hill
country: United States
facility: The Center for Cancer and Hematologic Disease
state: New Jersey
city: Red Bank
country: United States
facility: Hematology-Oncology of Central New Jersey
state: New Jersey
city: Toms River
country: United States
facility: Community Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Oncology Hematology Consultants
state: New Mexico
city: Armonk
country: United States
facility: Advanced Oncology Associates
state: New York
city: Brooklyn
country: United States
facility: Brooklyn VA
state: New York
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: Clifton Springs
country: United States
facility: Clifton Springs Hospital and Clinic
state: New York
city: Goshen
country: United States
facility: Goshen Medical Associates
state: New York
city: Latham
country: United States
facility: New York Oncology-Hematology,P.C./Capital District Hematology, Oncology Associates
state: New York
city: New York
country: United States
facility: Hematology/Oncology of Rockland
state: New York
city: Rochester
country: United States
facility: Upstate New York Cancer R & E
state: New York
city: Cary
country: United States
facility: Raleigh Hematology Associates, Wake Practice
state: North Carolina
city: Greenville
country: United States
facility: Quadrangle Medical Specialists, Southern Oncology Research
state: North Carolina
city: Bismarck
country: United States
facility: Mid Dakota Clinic
state: North Dakota
city: Columbus
country: United States
facility: Columbus CCOP
state: Ohio
city: Lemoyne
country: United States
facility: Central Pennsylvania Hematology & Medical Oncology Associates, P.C.
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Healthcare Network
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center/University of Pittsburgh Cancer Institute
state: Pennsylvania
city: Sayre
country: United States
facility: Guthrie Clinic Ltd
state: Pennsylvania
city: Memphis
country: United States
facility: Boston Cancer Group, PLC
state: Tennessee
city: Amarillo
country: United States
facility: Don & Sybil Harrington Cancer Center
state: Texas
city: Austin
country: United States
facility: Brackenridge Hospital
state: Texas
city: Austin
country: United States
facility: Southwest Regional Cancer Center
state: Texas
city: Lubbock
country: United States
facility: Southwest Cancer Center
state: Texas
city: Tacoma
country: United States
facility: Northwest Medical Specialties, PLLC
state: Washington
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
References: