Pemetrexed and Carboplatin in Locally Advanced or Metastatic Breast Cancer

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00072865

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Jun 1, 2003

Study Completion Date :

Sep 1, 2005

Outcome Measures

Primary Outcome Measures

antitumor activity []

Secondary Outcome Measures

duration of response;time to progressive disease;time to treatment failure []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
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	Russian Federation
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	Russian Federation

Sponsors and Collaborators

Eli Lilly and Company

Investigators

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