Oncology Medical News about Phase I; soft tissue sarcoma; liposomal doxorubicin

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Phase I study of non-pegylated liposomal doxorubicin in combination with ifosfamide in adult patients with metastatic soft tissue sarcomas
Investigational New Drugs, 07/14/09

Stroppa E et al. - In a study to evaluate the maximum tolerated dose (MTD) and safety of the combination of non-pegylated liposomal doxorubicin (Myocet) and ifosfamide in pts with metastatic soft tissue sarcomas, it was shown that the combination of intravenous Myocet 40 mg/m2 on day 1 and ifosfamide 3000 mg/m2 on days 1–3 every 3 wks is safe and feasible.

Methods

Cohorts of 4 pts with metastatic soft tissue sarcomas received up to 5 cycles of intravenous ifosfamide 3000 mg/m2 on days 1–3 in combination with escalating doses of intravenous Myocet on day 1 every 3 wks until dose limiting toxicity (DLT) in at least 1 pt.
Starting dose of Myocet was 40 mg/m2 to be escalated through 10 mg/m2 increase up to 80 mg/m2.
Toxicity was graded according to the National Cancer Institute Common Toxicity Criteria v3.0 (NCI-CTC v3.0).

Results

10 pts were enrolled and 8 of them received treatment.
Median age was 45 yrs, 3 pts were male and 5 were female.
DLT, consisting of neutropenic fever, was reached in 1 pt at dose level 2 (Myocet 50 mg/m2).
MTD and the recommended phase II dose is 40 mg/m2.

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