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

NCT ID: NCT00035152

Last Updated: 2016-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

444 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-06-30

Study Completion Date

2004-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Paclitaxel and carboplatin

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Locations

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Genesis Cancer Center

Hot Springs, Arkansas, United States

Site Status

Little Rock Hematology/Oncology Associates

Little Rock, Arkansas, United States

Site Status

Highlands Oncology Group

Springdale, Arkansas, United States

Site Status

Medical Oncology Care Associates

Orange, California, United States

Site Status

Naval Medical Center

San Diego, California, United States

Site Status

Danbury Hospital/Praxair Cancer Center

Danbury, Connecticut, United States

Site Status

Walter Reed Army Hospital

Washington D.C., District of Columbia, United States

Site Status

Washington VA Medical Center

Washington D.C., District of Columbia, United States

Site Status

Good Samaritan Medical Center

West Palm Beach, Florida, United States

Site Status

Wellstar Cobb Hospital

Austell, Georgia, United States

Site Status

Joliet Oncology/Hematology Associates,Ltd.

Joliet, Illinois, United States

Site Status

Mid Illinois Hematology and Oncology Associates, Ltd.

Normal, Illinois, United States

Site Status

West Suburban Center for Cancer Care

River Forest, Illinois, United States

Site Status

Community Cancer Care, Inc.

Indianapolis, Indiana, United States

Site Status

Associated Physicians & Surgeons Clinic, LLC

Terre Haute, Indiana, United States

Site Status

Mercy Cancer Center

Mason City, Iowa, United States

Site Status

Siouxland Hematology/Oncology Associates

Sioux City, Iowa, United States

Site Status

Jewish Medical Plaza

Louisville, Kentucky, United States

Site Status

University of Louisville

Louisville, Kentucky, United States

Site Status

Louisiana Oncology Associates

Lafayette, Louisiana, United States

Site Status

Louisiana State University Health Sciences Center

Shreveport, Louisiana, United States

Site Status

Maine General Medical Center

Waterville, Maine, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Hematology and Oncology Associates of Southern Michigan,P.C

Jackson, Michigan, United States

Site Status

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

Fairview-University Medical Center, University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Metro Minnesota CCOP

Saint Louis Park, Minnesota, United States

Site Status

Ellis Fischel Cancer Center

Columbia, Missouri, United States

Site Status

Creighton University Cancer Center

Omaha, Nebraska, United States

Site Status

The Center for Cancer and Hematologic Disease

Cherry Hill, New Jersey, United States

Site Status

Hematology-Oncology of Central New Jersey

Red Bank, New Jersey, United States

Site Status

Community Medical Center

Toms River, New Jersey, United States

Site Status

New Mexico Oncology Hematology Consultants

Albuquerque, New Mexico, United States

Site Status

Advanced Oncology Associates

Armonk, New York, United States

Site Status

Brooklyn VA

Brooklyn, New York, United States

Site Status

Maimonides Medical Center

Brooklyn, New York, United States

Site Status

Clifton Springs Hospital and Clinic

Clifton Springs, New York, United States

Site Status

Goshen Medical Associates

Goshen, New York, United States

Site Status

New York Oncology-Hematology,P.C./Capital District Hematology, Oncology Associates

Latham, New York, United States

Site Status

Hematology/Oncology of Rockland

New York, New York, United States

Site Status

Upstate New York Cancer R & E

Rochester, New York, United States

Site Status

Raleigh Hematology Associates, Wake Practice

Cary, North Carolina, United States

Site Status

Quadrangle Medical Specialists, Southern Oncology Research

Greenville, North Carolina, United States

Site Status

Mid Dakota Clinic

Bismarck, North Dakota, United States

Site Status

Columbus CCOP

Columbus, Ohio, United States

Site Status

Central Pennsylvania Hematology & Medical Oncology Associates, P.C.

Lemoyne, Pennsylvania, United States

Site Status

Albert Einstein Healthcare Network

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh Medical Center/University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, United States

Site Status

Guthrie Clinic Ltd

Sayre, Pennsylvania, United States

Site Status

Boston Cancer Group, PLC

Memphis, Tennessee, United States

Site Status

Don & Sybil Harrington Cancer Center

Amarillo, Texas, United States

Site Status

Brackenridge Hospital

Austin, Texas, United States

Site Status

Southwest Regional Cancer Center

Austin, Texas, United States

Site Status

Southwest Cancer Center

Lubbock, Texas, United States

Site Status

Northwest Medical Specialties, PLLC

Tacoma, Washington, United States

Site Status

Madigan Army Medical Center

Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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BMS TAX/MEN.12

Identifier Type: -

Identifier Source: org_study_id

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