Status:
COMPLETED
Navelbine and Capecitabine in the Treatment of Metastatic Breast Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Massachusetts General Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to find the highest dose of capecitabine and oral navelbine that can be given without causing severe side effects, and to determine the safety, tolerability, and effects (...
Detailed Description
* Not every patient will be receiving the same dose of capecitabine and navelbine. A small group will be enrolled onto the study and given certain doses of each drug. If they tolerate them well (have ...
Eligibility Criteria
Inclusion
- Histologically confirmed breast cancer with evidence of locally advanced or metastatic disease
- Female patients age 18 or older
- No more than three prior chemotherapeutic regimens in the metastatic setting
- ANC \> 1,500/mm3
- Platelet count \> 100,000/mm3
- SGOT \< 3 x ULN
- Bilirubin \< 1.5 x ULN
- Performance status of 0 or 1
- At least 3 weeks since prior chemotherapy or 2 weeks since prior radiation, surgery or any anticancer investigational agent
- Able to swallow and retain oral medications
- Measurable disease
Exclusion
- Prior vinca alkaloids
- Active gastrointestinal disease or disorder
- Pregnant or lactating
- Serious co-morbid medical or psychological condition
- Prior bone marrow or stem cell transplant
- Prior documented severe sensitivity to 5-FU
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00153907
Start Date
March 1 2002
End Date
September 1 2011
Last Update
February 7 2013
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115