A Phase II Study of a Combination of MTA (LY231514) and Gemcitabine in Patients With Metastatic Breast Cancer.
This study has been completed.
Sponsor:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00034489
First Posted: April 30, 2002
Last Update Posted: July 19, 2006
Information provided by:
Eli Lilly and Company
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Breast Neoplasms | Drug: pemetrexed Drug: gemcitabine | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | A Phase II Study of a Combination of MTA (LY231514) and Gemcitabine in Patients With Metastatic Breast Cancer. |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
MedlinePlus related topics:
Breast Cancer
U.S. FDA Resources
Further study details as provided by Eli Lilly and Company:
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.
Eligibility
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00034489
Locations
| United States, Minnesota | |
| Rochester, Minnesota, United States | |
Sponsors and Collaborators
Eli Lilly and Company
More Information
| ClinicalTrials.gov Identifier: | NCT00034489 History of Changes |
| Other Study ID Numbers: |
2245 H3E-MC-JMCF |
| First Submitted: | April 29, 2002 |
| First Posted: | April 30, 2002 |
| Last Update Posted: | July 19, 2006 |
| Last Verified: | July 2006 |
Keywords provided by Eli Lilly and Company:
|
metastatic breast cancer combination therapy Alimta |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Gemcitabine Pemetrexed Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |