NCT00035152

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
444

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2000

Longer than P75 for phase_3

Geographic Reach
1 country

56 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2000

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 3, 2002

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
Last Updated

September 19, 2016

Status Verified

September 1, 2016

First QC Date

May 2, 2002

Last Update Submit

September 16, 2016

Conditions

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (56)

Genesis Cancer Center

Hot Springs, Arkansas, 71913, United States

Location

Little Rock Hematology/Oncology Associates

Little Rock, Arkansas, 72205, United States

Location

Highlands Oncology Group

Springdale, Arkansas, 72764, United States

Location

Medical Oncology Care Associates

Orange, California, 92868, United States

Location

Naval Medical Center

San Diego, California, 92134, United States

Location

Danbury Hospital/Praxair Cancer Center

Danbury, Connecticut, 06810, United States

Location

Walter Reed Army Hospital

Washington D.C., District of Columbia, 20307, United States

Location

Washington VA Medical Center

Washington D.C., District of Columbia, 20422, United States

Location

Good Samaritan Medical Center

West Palm Beach, Florida, 33401, United States

Location

Wellstar Cobb Hospital

Austell, Georgia, 30060, United States

Location

Joliet Oncology/Hematology Associates,Ltd.

Joliet, Illinois, 60435, United States

Location

Mid Illinois Hematology and Oncology Associates, Ltd.

Normal, Illinois, 61761, United States

Location

West Suburban Center for Cancer Care

River Forest, Illinois, 60305, United States

Location

Community Cancer Care, Inc.

Indianapolis, Indiana, 46202, United States

Location

Associated Physicians & Surgeons Clinic, LLC

Terre Haute, Indiana, 47804, United States

Location

Mercy Cancer Center

Mason City, Iowa, 50401, United States

Location

Siouxland Hematology/Oncology Associates

Sioux City, Iowa, 51101, United States

Location

Jewish Medical Plaza

Louisville, Kentucky, 40202, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Louisiana Oncology Associates

Lafayette, Louisiana, 70506, United States

Location

Louisiana State University Health Sciences Center

Shreveport, Louisiana, 71130, United States

Location

Maine General Medical Center

Waterville, Maine, 04901, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Hematology and Oncology Associates of Southern Michigan,P.C

Jackson, Michigan, 49201, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Fairview-University Medical Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Metro Minnesota CCOP

Saint Louis Park, Minnesota, 55416, United States

Location

Ellis Fischel Cancer Center

Columbia, Missouri, 65203, United States

Location

Creighton University Cancer Center

Omaha, Nebraska, 68131, United States

Location

The Center for Cancer and Hematologic Disease

Cherry Hill, New Jersey, 08003, United States

Location

Hematology-Oncology of Central New Jersey

Red Bank, New Jersey, 07701, United States

Location

Community Medical Center

Toms River, New Jersey, 08755, United States

Location

New Mexico Oncology Hematology Consultants

Albuquerque, New Mexico, 87109, United States

Location

Advanced Oncology Associates

Armonk, New York, 10504, United States

Location

Brooklyn VA

Brooklyn, New York, 11209, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11209, United States

Location

Clifton Springs Hospital and Clinic

Clifton Springs, New York, 14432, United States

Location

Goshen Medical Associates

Goshen, New York, 10924, United States

Location

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

Latham, New York, 12110, United States

Location

Hematology/Oncology of Rockland

New York, New York, United States

Location

Upstate New York Cancer R & E

Rochester, New York, 14623, United States

Location

Raleigh Hematology Associates, Wake Practice

Cary, North Carolina, 27609, United States

Location

Quadrangle Medical Specialists, Southern Oncology Research

Greenville, North Carolina, 27834, United States

Location

Mid Dakota Clinic

Bismarck, North Dakota, 58501, United States

Location

Columbus CCOP

Columbus, Ohio, 43206, United States

Location

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

Lemoyne, Pennsylvania, 17043, United States

Location

Albert Einstein Healthcare Network

Philadelphia, Pennsylvania, 19141, United States

Location

University of Pittsburgh Medical Center/University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

Guthrie Clinic Ltd

Sayre, Pennsylvania, 18840, United States

Location

Boston Cancer Group, PLC

Memphis, Tennessee, 38104, United States

Location

Don & Sybil Harrington Cancer Center

Amarillo, Texas, 79106, United States

Location

Brackenridge Hospital

Austin, Texas, 78701, United States

Location

Southwest Regional Cancer Center

Austin, Texas, 78705, United States

Location

Southwest Cancer Center

Lubbock, Texas, 79415, United States

Location

Northwest Medical Specialties, PLLC

Tacoma, Washington, 98405, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

PaclitaxelCarboplatin

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination Complexes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 2, 2002

First Posted

May 3, 2002

Study Start

June 1, 2000

Study Completion

December 1, 2004

Last Updated

September 19, 2016

Record last verified: 2016-09

Locations