Oncology Medical News about metastatic carcinoma of the breast;prolonged-infusion Gemcitabine combined with Cyclophosphamide

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Phase I study of prolonged-infusion gemcitabine combined with cyclophosphamide in patients with metastatic carcinoma of the breast: tolerability of an optimal dose schedule
Oncology (Karger), 06/30/09

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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