Pemetrexed and Carboplatin in Locally Advanced or Metastatic Breast Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

November 12, 2003

Last Updated Date

January 24, 2007

Start Date ^ICMJE

June 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

antitumor activity

Original Primary Outcome Measures ^ICMJE

- antitumor activity

Change History

Complete list of historical versions of study NCT00072865 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

- duration of response
- time to progressive disease
- time to treatment failure

Descriptive Information

Brief Title ^ICMJE

Pemetrexed and Carboplatin in Locally Advanced or Metastatic Breast Cancer

Official Title ^ICMJE

A Phase II Study of Alimta and Carboplatin in the Treatment of Patients With Locally Advanced or Metastatic Breast Cancer

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Breast Cancer
Neoplasm Metastasis

Intervention ^ICMJE

Drug: Pemetrexed
Drug: Carboplatin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Russian Federation

Administrative Information

NCT ID ^ICMJE

NCT00072865

Responsible Party

Study ID Numbers ^ICMJE

7771, H3E-MW-JMGJ

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

Eli Lilly and Company

Verification Date

January 2007

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