Pemetrexed and Carboplatin in Locally Advanced or Metastatic Breast Cancer

This study has been completed.

First Received: November 12, 2003 Last Updated: January 24, 2007 History of Changes

Sponsor:	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

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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Carboplatin Pemetrexed Pemetrexed disodium

U.S. FDA Resources

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

No publications provided

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

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Breast Neoplasms
Enzyme Inhibitors
Carboplatin
Folic Acid Antagonists

Pharmacologic Actions
Pemetrexed
Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Therapeutic Uses
Neoplasm Metastasis
Breast Diseases

ClinicalTrials.gov processed this record on November 27, 2009