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

This study has been completed.

First Received: May 2, 2002 Last Updated: June 27, 2008 History of Changes

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00035152

Purpose

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.

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: Paclitaxel and carboplatin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Paclitaxel Carboplatin

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Estimated Enrollment:	444
Study Start Date:	June 2000
Estimated Study Completion Date:	December 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035152

Show 56 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

More Information

Additional Information:

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	BMS TAX/MEN.12
Study First Received:	May 2, 2002
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00035152 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Thoracic Neoplasms
Carboplatin
Antimitotic Agents
Carcinoma
Respiratory Tract Diseases
Lung Neoplasms
Paclitaxel

Lung Diseases
Tubulin Modulators
Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Antimitotic Agents
Carboplatin
Pharmacologic Actions
Carcinoma
Neoplasms

Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Paclitaxel
Therapeutic Uses
Lung Diseases
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 11, 2009