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

Pemetrexed and Carboplatin in Locally Advanced or Metastatic Breast Cancer

This study has been completed.

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00072865

Purpose

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	Intervention	Phase
Breast Cancer Neoplasm Metastasis	Drug: Pemetrexed Drug: Carboplatin	Phase II

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer

Drug Information available for:

Carboplatin Pemetrexed disodium Pemetrexed

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

antitumor activity

Secondary Outcome Measures:

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

Estimated Enrollment:	50
Study Start Date:	June 2003
Estimated Study Completion Date:	September 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00072865

Locations


Russian Federation, Russia
	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


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

Study ID Numbers:	7771, H3E-MW-JMGJ
First Received:	November 12, 2003
Last Updated:	January 24, 2007
ClinicalTrials.gov Identifier:	NCT00072865
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Folic Acid

Pemetrexed

Skin Diseases

Neoplasm Metastasis

Breast Neoplasms

Carboplatin

Breast Diseases

Additional relevant MeSH terms:

Antimetabolites

Neoplastic Processes

Neoplasms

Antimetabolites, Antineoplastic

Pathologic Processes

Neoplasms by Site

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Enzyme Inhibitors

Folic Acid Antagonists

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008