Status:

COMPLETED

Pemetrexed and Carboplatin in Locally Advanced or Metastatic Breast Cancer

Lead Sponsor:

Eli Lilly and Company

Conditions:

Breast Cancer

Neoplasm Metastasis

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

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 metasta...

Eligibility Criteria

Inclusion

  • 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

  • Prior treatment with pemetrexed
  • Pregnant or breast feeding
  • Brain Metastasis
  • unable or unwilling to take folic acid, vitamin B12 supplementation, or dexamethasone.

Key Trial Info

Start Date :

June 1 2003

Trial Type :

INTERVENTIONAL

End Date :

September 1 2005

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT00072865

Start Date

June 1 2003

End Date

September 1 2005

Last Update

January 26 2007

Active Locations (2)

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Page 1 of 1 (2 locations)

1

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, Russia

2

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, Russia