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.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00035152
First received: May 2, 2002
Last updated: June 27, 2008
Last verified: August 2007

May 2, 2002
June 27, 2008
June 2000
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Complete list of historical versions of study NCT00035152 on ClinicalTrials.gov Archive Site
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Study Comparing Weekly Taxol and Carboplatin vs Standard Taxol and Carboplatin Regimen for Stage IIIB or IV Non-Small-Cell Lung Cancer
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.

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Non-Small-Cell Lung
Drug: Paclitaxel and carboplatin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
444
December 2004
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00035152
BMS TAX/MEN.12
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Bristol-Myers Squibb
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Bristol-Myers Squibb
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP