Weekly Low-dose Paclitaxel (Phyxol) Plus 24-Hour Infusion of Cisplatin as First-line Chemotherapy for Metastatic Breast Cancer
Breast cancer is one of the leading causes of cancer death for women in Taiwan. We have
recently demonstrated that combination of paclitaxel and cisplatin, at conventional doses,
is highly effective in the treatment of breast cancer. However, the acute and cumulative
toxicities of paclitaxel have been troublesome to a significant portion of the patients.
Several lines of evidence suggested that weekly paclitaxel, at a much lower dose range of 40
to 50 mg/m2 per week, may be as effective as that of the conventional doses of paclitaxel
(80 to 90 mg/m2 per week) for patients with metastatic ovarian and lung cancers. The
low-dose regimen of paclitaxel may significantly improve the compliance of the patients.
This open-label phase II trial is designed to test this hypothesis.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary endpoint of this phase II trial is the objective response rate of the stage I (low-dose) regimen.
Yen-Shen Lu, M.D.
Department of Oncology , National Taiwan University Hospital
Taiwan: Department of Health