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

Tracking Information
First Received Date ^ICMJE	May 2, 2002
Last Updated Date	June 27, 2008
Start Date ^ICMJE	June 2000
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00035152 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study Comparing Weekly Taxol and Carboplatin vs Standard Taxol and Carboplatin Regimen for Stage IIIB or IV Non-Small-Cell Lung Cancer
Official Title ^ICMJE	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.
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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Condition ^ICMJE	Carcinoma, Non-Small-Cell Lung
Intervention ^ICMJE	Drug: Paclitaxel and carboplatin
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	444
Completion Date	December 2004
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00035152
Responsible Party
Study ID Numbers ^ICMJE	BMS TAX/MEN.12
Study Sponsor ^ICMJE	Bristol-Myers Squibb
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Bristol-Myers Squibb
Verification Date	August 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP