A Trial Of Gemcitabine Plus Paclitaxel And Gemcitabine Plus Docetaxel In Metastatic Breast Cancer
A Phase II Randomized Trial Of Gemcitabine Plus Paclitaxel And Gemcitabine Plus Docetaxel In Patients With Metastatic Breast Cancer
2 other identifiers
interventional
120
1 country
2
Brief Summary
The combination of docetaxel and gemcitabine has shown significant activity in patients with metastatic breast cancer. Several studies have activity in patients of multiple lines of therapy, including patients that have been treated with prior taxane therapy. Overall responses have ranged from 30% to 79%. The major side effects of the combination chemotherapy have been neutropenia, anemia, asthenia, neuropathy, nausea, mucositis, and neutropenic fever
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2003
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedJanuary 26, 2007
January 1, 2007
September 12, 2005
January 24, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
Estimate the response rate of two regimens separately.
Secondary Outcomes (2)
Estimate the following activities of two regimens separately:Progression-free survival;Time to progressive disease;duration of response;Overall survival, changes in performance status
Nature of toxicities experienced on each arm of the study
Interventions
Eligibility Criteria
You may qualify if:
- Advanced or metastatic breast cancer
- Disease that can be measured by the physician or radiologic test.
- May have had one chemotherapy treatment for advanced or metastatic disease.
- Patients may have received any prior adjuvant chemotherapy, including taxane containing regimens, provided this treatment was completed at least 6 months prior to enrollment.
- Patients may have received prior hormone therapy or immunotherapy.
You may not qualify if:
- Patients with only non-measurable disease
- Cancer that has spread to the brain
- A patient who received a taxane with metastatic disease.
- Pregnancy
- Patients who received prior gemcitabine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
For additional information regarding investigative sites for this trial, contact 1-877-CT-LILLY (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.
Nashville, Tennessee, 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 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Katy, Texas, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 19, 2005
Study Start
December 1, 2003
Study Completion
November 1, 2006
Last Updated
January 26, 2007
Record last verified: 2007-01