NCT00191672CompletedPhase 2
A Phase II Randomized Trial Of Gemcitabine Plus Paclitaxel And Gemcitabine Plus Docetaxel In Patients With Metastatic Breast Cancer
Eli Lilly and Company2 sites in 1 country120 target enrollmentStarted: December 1, 2003Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Estimate the response rate of two regimens separately.
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Estimate the response rate of two regimens separately.
Secondary Outcomes
- 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
Investigators
Study Sites (2)
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