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Pemetrexed and Carboplatin in Locally Advanced or Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00072865
Recruitment Status : Completed
First Posted : November 13, 2003
Last Update Posted : January 26, 2007
Sponsor:
Information provided by:
Eli Lilly and Company

Study Description
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Brief Summary:
This is a nonrandomized study of pemetrexed plus carboplatin, with the primary objective of determining the efficacy of the combination in tumor reduction, in patients with locally advanced or metastatic breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Neoplasm Metastasis Drug: Pemetrexed Drug: Carboplatin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Alimta and Carboplatin in the Treatment of Patients With Locally Advanced or Metastatic Breast Cancer
Study Start Date : June 2003
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. antitumor activity

Secondary Outcome Measures :
  1. duration of response;time to progressive disease;time to treatment failure

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologic or cytologic diagnosis of locally advanced or metastatic breast cancer
  • No prior chemotherapy for locally advanced or metastatic breast disease.
  • Patient may have received prior adjuvant therapy finished greater than 1 year prior to enrollment.
  • Adequate bone marrow, liver and kidney function
  • RECIST criteria for disease status

Exclusion Criteria:

  • Prior treatment with pemetrexed
  • Pregnant or breast feeding
  • Brain Metastasis
  • unable or unwilling to take folic acid, vitamin B12 supplementation, or dexamethasone.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT00072865


Locations
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Russian Federation
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Moscow, Russia, Russian Federation
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Saint Petersburg, Russia, Russian Federation
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
More Information
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ClinicalTrials.gov Identifier: NCT00072865    
Other Study ID Numbers: 7771
H3E-MW-JMGJ
First Posted: November 13, 2003    Key Record Dates
Last Update Posted: January 26, 2007
Last Verified: January 2007
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
 Carboplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors