A Phase I Study of Oral Navelbine and Capecitabine in the Treatment of Metastatic Breast Cancer
- 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 few or easily manageable side effects), the next small
group of people enrolled will receive a higher dose of one of the drugs. This will
continue until we find the highest doses of the drugs that can be given without causing
serious or unmanageable side effects.
- Patients will be given oral navelbine on days 1 and 8 of each cycle, unless they are at
the highest dose. In which case, they will be given navelbine on days 1, 8 and 15.
Capecitabine will be given on days 1-14 of each cycle in two divided doses
approximately 12 hours apart.
- While patients are on the study they will have the following tests and procedures
performed: physical examination every 3 weeks; routine blood work every week; extensive
laboratory tests every 3 weeks; disease status will be checked every 6 weeks (2 cycles)
unless there are symptoms of disease progression.
- The weekly treatment will continue unless there is disease progression or unacceptable
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To define the maximally tolerated dose and evaluate the feasibility and toxicity of capecitabine and oral navelbine administered in combination.
Craig A. Bunnell, MD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|