Pemetrexed Plus Gemcitabine in Metastatic Breast Cancer Patients After Receiving Taxane Therapy
NCT ID: NCT00063570
Last Updated: 2009-05-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
73 participants
INTERVENTIONAL
2003-07-31
2008-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
Pemetrexed
500 mg/m2, intravenous (IV), every 14 days, until disease progression
Gemcitabine
1500 mg/m2, intravenous (IV), every 14 days, until disease progression
B
Gemcitabine
1000 mg/m2, intravenous (IV), on Days 1 and 8 of 21-day cycle, until disease progression
Pemetrexed
500 mg/m2, intravenous (IV), every 21 days, until disease progression
Interventions
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Pemetrexed
500 mg/m2, intravenous (IV), every 14 days, until disease progression
Gemcitabine
1500 mg/m2, intravenous (IV), every 14 days, until disease progression
Gemcitabine
1000 mg/m2, intravenous (IV), on Days 1 and 8 of 21-day cycle, until disease progression
Pemetrexed
500 mg/m2, intravenous (IV), every 21 days, until disease progression
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Less than 3 different chemotherapy treatments for metastatic disease.
* Prior treatment with hormonal and/or radiation therapy.
* Must have disease that can be measured.
* Must be able to take care of self needs for example personal hygiene
Exclusion Criteria
* Cancer that has spread to the brain.
* Treatment with Gemcitabine or Pemetrexed
* Unable to take folic acid or Vitamin B12
* Treatment for another cancer within the last 5 years
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Eli Lilly
Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 317-615-4559 Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Aurora, Colorado, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Plantation, Florida, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Morrisville, North Carolina, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Philadelphia, Pennsylvania, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Dallas, Texas, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Seattle, Washington, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
San Juan, , Puerto Rico
Countries
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Other Identifiers
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H3E-US-JMEO
Identifier Type: -
Identifier Source: secondary_id
5141
Identifier Type: -
Identifier Source: org_study_id