- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00034489
A Phase II Study of a Combination of MTA (LY231514) and Gemcitabine in Patients With Metastatic Breast Cancer.
July 18, 2006 updated by: Eli Lilly and Company
This is a study to explore how well the combination of LY231514 and Gemcitabine work together in patients with breast cancer that has spread beyond the location of the original tumor.
Patients must have previously received treatment with anthracycline and taxane chemotherapy drugs.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Gemcitabine is given by vein over 30 minutes on days 1 & 8 of each 21-day cycle.
LY231514 is also given by vein over 10 minutes on day 8, following the Gemcitabine injection.
Vitamin supplementation with oral folic acid and injectable B12 is initiated 7-10 days prior to the first dose of LY231514, and continuing throughout the patient's participation.
Vitamin B12 is administered approximately every 9 weeks after the first injection.
Appropriate antiemetic medication should be given to all patients.
Dexamethasone 4mg PO twice daily is given for 3 days per cycle, beginning 1 day prior to LY231514 dosing.
This is given to prevent or lessen the possibility of a rash.
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Rochester, Minnesota, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- confirmed diagnosis of breast cancer
- measurable disease
- received prior anthracycline and taxane
- life expectancy > 3 months
- acceptable lab results
Exclusion Criteria:
- >3 prior regimens
- prior treatment with protocol drugs
- prior (pelvic) radiation
- active CNS metastasis
- inability to take oral vitamins
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
April 29, 2002
First Submitted That Met QC Criteria
April 29, 2002
First Posted (Estimate)
April 30, 2002
Study Record Updates
Last Update Posted (Estimate)
July 19, 2006
Last Update Submitted That Met QC Criteria
July 18, 2006
Last Verified
July 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Folic Acid Antagonists
- Gemcitabine
- Pemetrexed
Other Study ID Numbers
- 2245
- H3E-MC-JMCF
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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