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

September 16, 2016 updated by: Bristol-Myers Squibb

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

444

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Genesis Cancer Center
      • Little Rock, Arkansas, United States, 72205
        • Little Rock Hematology/Oncology Associates
      • Springdale, Arkansas, United States, 72764
        • Highlands Oncology Group
    • California
      • Orange, California, United States, 92868
        • Medical Oncology Care Associates
      • San Diego, California, United States, 92134
        • Naval Medical Center
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Danbury Hospital/Praxair Cancer Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20422
        • Washington VA Medical Center
      • Washington, District of Columbia, United States, 20307
        • Walter Reed Army Hospital
    • Florida
      • West Palm Beach, Florida, United States, 33401
        • Good Samaritan Medical Center
    • Georgia
      • Austell, Georgia, United States, 30060
        • WellStar Cobb Hospital
    • Illinois
      • Joliet, Illinois, United States, 60435
        • Joliet Oncology/Hematology Associates,Ltd.
      • Normal, Illinois, United States, 61761
        • Mid Illinois Hematology and Oncology Associates, Ltd.
      • River Forest, Illinois, United States, 60305
        • West Suburban Center for Cancer Care
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Community Cancer Care, Inc.
      • Terre Haute, Indiana, United States, 47804
        • Associated Physicians & Surgeons Clinic, LLC
    • Iowa
      • Mason City, Iowa, United States, 50401
        • Mercy Cancer Center
      • Sioux City, Iowa, United States, 51101
        • Siouxland Hematology/Oncology Associates
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
      • Louisville, Kentucky, United States, 40202
        • Jewish Medical Plaza
    • Louisiana
      • Lafayette, Louisiana, United States, 70506
        • Louisiana Oncology Associates
      • Shreveport, Louisiana, United States, 71130
        • Louisiana State University Health Sciences Center
    • Maine
      • Waterville, Maine, United States, 04901
        • Maine General Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Jackson, Michigan, United States, 49201
        • Hematology and Oncology Associates of Southern Michigan,P.C
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, United States, 55455
        • Fairview-University Medical Center, University of Minnesota
      • St. Louis Park, Minnesota, United States, 55416
        • Metro Minnesota CCOP
    • Missouri
      • Columbia, Missouri, United States, 65203
        • Ellis Fischel Cancer Center
    • Nebraska
      • Omaha, Nebraska, United States, 68131
        • Creighton University Cancer Center
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08003
        • The Center for Cancer and Hematologic Disease
      • Red Bank, New Jersey, United States, 07701
        • Hematology-Oncology of Central New Jersey
      • Toms River, New Jersey, United States, 08755
        • Community Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • New Mexico Oncology Hematology Consultants
    • New York
      • Armonk, New York, United States, 10504
        • Advanced Oncology Associates
      • Brooklyn, New York, United States, 11209
        • Brooklyn VA
      • Brooklyn, New York, United States, 11209
        • Maimonides Medical Center
      • Clifton Springs, New York, United States, 14432
        • Clifton Springs Hospital and Clinic
      • Goshen, New York, United States, 10924
        • Goshen Medical Associates
      • Latham, New York, United States, 12110
        • New York Oncology-Hematology,P.C./Capital District Hematology, Oncology Associates
      • New York, New York, United States
        • Hematology/Oncology of Rockland
      • Rochester, New York, United States, 14623
        • Upstate New York Cancer R & E
    • North Carolina
      • Cary, North Carolina, United States, 27609
        • Raleigh Hematology Associates, Wake Practice
      • Greenville, North Carolina, United States, 27834
        • Quadrangle Medical Specialists, Southern Oncology Research
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Mid Dakota Clinic
    • Ohio
      • Columbus, Ohio, United States, 43206
        • Columbus CCOP
    • Pennsylvania
      • Lemoyne, Pennsylvania, United States, 17043
        • Central Pennsylvania Hematology & Medical Oncology Associates, P.C.
      • Philadelphia, Pennsylvania, United States, 19141
        • Albert Einstein Healthcare Network
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center/University of Pittsburgh Cancer Institute
      • Sayre, Pennsylvania, United States, 18840
        • Guthrie Clinic Ltd
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Boston Cancer Group, PLC
    • Texas
      • Amarillo, Texas, United States, 79106
        • Don & Sybil Harrington Cancer Center
      • Austin, Texas, United States, 78701
        • Brackenridge Hospital
      • Austin, Texas, United States, 78705
        • Southwest Regional Cancer Center
      • Lubbock, Texas, United States, 79415
        • Southwest Cancer Center
    • Washington
      • Tacoma, Washington, United States, 98405
        • Northwest Medical Specialties, PLLC
      • Tacoma, Washington, United States, 98431
        • Madigan Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2000

Study Completion

December 1, 2004

Study Registration Dates

First Submitted

May 2, 2002

First Submitted That Met QC Criteria

May 2, 2002

First Posted (Estimate)

May 3, 2002

Study Record Updates

Last Update Posted (Estimate)

September 19, 2016

Last Update Submitted That Met QC Criteria

September 16, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMS TAX/MEN.12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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