Phase I study of prolonged-infusion gemcitabine combined with cyclophosphamide in patients with metastatic carcinoma of the breast: tolerability of an optimal dose schedule
Estephan F et al. - In a study to determine the maximum tolerated dose (MTD) of prolonged-infusion gemcitabine combined with cyclophosphamide in pts with metastatic breast carcinoma (MBC), it was found that the MTD can be given safely every 4 wks to pts with MBC. Methods- Patients with MBC were treated with gemcitabine infusion at 10 mg/m2/min and cyclophosphamide by intravenous piggyback injection, 4 hr after initiation of the infusion.
- 3-6 pts were treated at a particular dose level until the MTD was determined.
Results- 44 pts received 197 courses of therapy.
- Both drugs were given on days 1, 8 and 15 to 14 pts (68 courses).
- Delayed white blood cell recovery necessitated first protocol amendment to drop cyclophosphamide on days 8 and 15 in 9 pts (43 cycles).
- A second amendment was needed to drop gemcitabine on day 15 because of thrombocytopenia in 21 pts (86 courses).
- Dose-limiting toxicity was thrombocytopenia.
- MTD of an optimal dose schedule was 800 mg/m2 gemcitabine infused at a rate of 10 mg/m2/min on days 1 and 8, and 400 mg/m2 cyclophosphamide, by intravenous piggyback injection, on day 1, 4 h after initiation of gemcitabine infusion.
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