Taxotere Plus Weekly Navelbine and G-CSF: A Phase II Study in Stage IV Breast Cancer
Preclinical data suggest that there may be synergy between vinorelbine and paclitaxel when
the two drugs are used in combination such that the effect of the two together may be better
than either alone. Clinical data suggest that the use of concurrent G-CSF with paclitaxel
and vinorelbine permits the delivery of both agents at approximately 70% of the "full" dose
for either, used alone without G-CSF support, with myelosuppression as the usual
dose-limiting toxicity and no unusual or unexpected complications. Encouragingly, 8/20 (40%)
patients had objective responses, with three complete remissions (15%) in this program of
third-line therapy. Therefore, we now propose to combine docetaxel at about 70% of "full"
dose with vinorelbine at 27.5 mg/m2, the "phase II" dose defined in the previous trial.
Docetaxel will be given on day 1 followed by vinorelbine on days 8 and 15, with G-CSF to be
administered on all days except that of docetaxel administration. The cycle is to be
repeated every three weeks.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response to treatment
Until disease progression
Julie R. Gralow, M.D.
University of Washington
United States: Institutional Review Board
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