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Oral Taxane in Combination With Pemetrexed (Alimta) in Patients With Recurrent Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00103831
Recruitment Status : Completed
First Posted : February 16, 2005
Last Update Posted : March 2, 2010
Sponsor:
Information provided by:
Bristol-Myers Squibb

Study Description
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Brief Summary:
A phase I-II dose ranging study of BMS-275183 (oral taxane) in combination with pemetrexed (Alimta) in patients with recurrent Non-Small Cell Lung Cancer (NSCLC). The safety and efficacy of this combination will be studied.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Oral Taxane Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase I Alimta Combination With BMS-275183 (Oral Taxane)
Actual Primary Completion Date : May 2005

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Advanced or metastatic pretreated NSCLC
  • Measurable disease
  • Adequate hematologic, hepatic and renal functions.
  • ECOG Performance Status 0-2

Exclusion Criteria:

  • Inability to swallow capsules
  • Recent significant cardiovascular disease
  • Women who are pregnant or breastfeeding
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00103831


Locations
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United States, Colorado
Local Institution
Denver, Colorado, United States
United States, Minnesota
Local Institution
Rochester, Minnesota, United States
Canada, Ontario
Local Institution
Toronto, Ontario, Canada
Sponsors and Collaborators
Bristol-Myers Squibb
More Information
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ClinicalTrials.gov Identifier: NCT00103831    
Other Study ID Numbers: CA165-021
First Posted: February 16, 2005    Key Record Dates
Last Update Posted: March 2, 2010
Last Verified: August 2008
Keywords provided by Bristol-Myers Squibb:
NSCLC - non-small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Taxane
Antineoplastic Agents