Combination Chemotherapy of Gemcitabine and Paclitaxel for Metastatic Breast Cancer
NCT ID: NCT00334802
Last Updated: 2010-03-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
62 participants
INTERVENTIONAL
2006-06-30
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
gemcitabine
Phase 1: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles (dose escalation)
Phase 2: dose determined by phase 1
paclitaxel
Phase 1: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
Phase 2: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
Interventions
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gemcitabine
Phase 1: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles (dose escalation)
Phase 2: dose determined by phase 1
paclitaxel
Phase 1: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
Phase 2: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Received adjuvant/neo-adjuvant chemotherapy for breast cancer with anthracycline regimen
* To have at least one measurable region
* Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
* To have adequate organ function (bone marrow, liver and renal function)
Exclusion Criteria
* To have inflammatory breast cancer
* Within 28 days after the latest chemotherapy or radiotherapy, 14 days after the latest hormonal/immunotherapy or 7 days after surgery
* To have brain metastases with symptoms
* To have severe complication (cardiac infarction, infection, drug hypersensitivity or diabetes)
20 Years
74 Years
FEMALE
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 1-317-615-4559 Mon - Fri 9 AM - 5 PM 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 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Aichi, , Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chiba, , Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ehime, , Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fukuoka, , Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Gunma, , Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hiroshima, , Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hokkaido, , Japan
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Kagoshima, , Japan
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Kanagawa, , Japan
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Kumamoto, , Japan
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Numakunai, , Japan
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Osaka, , Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Saitama, , Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Shizuoka, , Japan
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Tokyo, , Japan
Countries
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Other Identifiers
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B9E-JE-MB22
Identifier Type: OTHER
Identifier Source: secondary_id
9066
Identifier Type: -
Identifier Source: org_study_id
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