Pemetrexed as First Line Chemotherapy for Advanced Breast Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

July 28, 2003

Last Updated Date

June 21, 2007

Start Date ^ICMJE

May 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

To assess tumor response.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00065533 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To evaluate the toxicity profile of two doses of pemetrexed in breast cancer patients.
To assess the following time-to-event efficacy variables: time to response, duration of response, duration of stable disease, time to documented progressive disease, time to treatment failure, progression-free survival, and overall survival.
To identify the relationships, if any, that may exist between various molecular markers and pemetrexed efficacy and toxicity.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Pemetrexed as First Line Chemotherapy for Advanced Breast Cancer

Official Title ^ICMJE

Study of Two Doses of ALIMTA (Pemetrexed) as First Line Chemotherapy for Advanced Breast Cancer

Brief Summary

The purposes of this study are to determine the safety of pemetrexed and any side effects that might be associated with it, whether pemetrexed can help patients with breast cancer and how much pemetrexed should be given to patients.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Drug: pemetrexed

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

June 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Be at least 18 years of old.
Have been diagnosed with breast cancer
At least one year disease-free interval after initial treatment.
Have pre-study laboratory tests that are within the requirements of this study.
Be able to visit the doctor's office weekly during the treatment period.

Exclusion Criteria:

To be pregnant or breastfeeding.
To be currently taking aspirin or aspirin- like medicine and unable to stop for a few days during each cycle of therapy.
To have received prior chemotherapy for the treatment of metastatic cancer. Patients may have received prior hormonal treatment.
To have another illness that your doctor thinks would make you unable to participate.
To be unable or not willing to take folic acid and vitamin B12.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Argentina, Belgium, Germany, Romania, Spain, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00065533

Responsible Party

Study ID Numbers ^ICMJE

7491, H3E-MC-JMGE

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

June 2007

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