OBJECTIVE: The aim of this study was to evaluate the maximum tolerated dose (MTD) and safety of the combination of non- pegylated liposomal doxorubicin (Myocet) and ifosfamide in patients with metastatic soft tissue sarcomas. METHODS: Cohorts of four patients with metastatic soft tissue sarcomas received up to five cycles of intravenous ifosfamide 3000 mg/m2 on days 1- 3 in combination with escalating doses of intravenous Myocet on day 1 every 3 weeks until dose limiting toxicity (DLT) in at least one patient. 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: Ten patients were enrolled in the study and 8 of them received the treatment. Median age was 45 years, 3 patients were male and 5 were female. DLT, consisting of neutropenic fever, was reached in one patient at dose level 2 (Myocet 50 mg/m2). Therefore, the MTD and the recommended phase II dose is 40 mg/m2. CONCLUSIONS: The combination of intravenous Myocet 40 mg/m2 on day 1 and ifosfamide 3,000 mg/m2 on days 1-3 every 3 weeks is safe and feasible; a phase II study is ongoing.
OBJECTIVE: The aim of this study was to evaluate the maximum tolerated dose (MTD) and safety of the combination of non- pegylated liposomal doxorubicin (Myocet) and ifosfamide in patients with metastatic soft tissue sarcomas. METHODS: Cohorts of four patients with metastatic soft tissue sarcomas received up to five cycles of intravenous ifosfamide 3000 mg/m2 on days 1- 3 in combination with escalating doses of intravenous Myocet on day 1 every 3 weeks until dose limiting toxicity (DLT) in at least one patient. 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: Ten patients were enrolled in the study and 8 of them received the treatment. Median age was 45 years, 3 patients were male and 5 were female. DLT, consisting of neutropenic fever, was reached in one patient at dose level 2 (Myocet 50 mg/m2). Therefore, the MTD and the recommended phase II dose is 40 mg/m2. CONCLUSIONS: The combination of intravenous Myocet 40 mg/m2 on day 1 and ifosfamide 3,000 mg/m2 on days 1-3 every 3 weeks is safe and feasible; a phase II study is ongoing.
Authors: J Verweij; H T Mouridsen; O S Nielssen; P J Woll; R Somers; A T van Oosterom; M Van Glabbeke; T Tursz Journal: Crit Rev Oncol Hematol Date: 1995-10 Impact factor: 6.312
Authors: G Batist; G Ramakrishnan; C S Rao; A Chandrasekharan; J Gutheil; T Guthrie; P Shah; A Khojasteh; M K Nair; K Hoelzer; K Tkaczuk; Y C Park; L W Lee Journal: J Clin Oncol Date: 2001-03-01 Impact factor: 44.544
Authors: K Antman; J Crowley; S P Balcerzak; S E Rivkin; G R Weiss; A Elias; R B Natale; R M Cooper; B Barlogie; D L Trump Journal: J Clin Oncol Date: 1993-07 Impact factor: 44.544
Authors: M S Ewer; M K Ali; B Mackay; S Wallace; M Valdivieso; S S Legha; R S Benjamin; T P Haynie Journal: J Clin Oncol Date: 1984-02 Impact factor: 44.544
Authors: V Valero; A U Buzdar; R L Theriault; N Azarnia; G A Fonseca; J Willey; M Ewer; R S Walters; B Mackay; D Podoloff; D Booser; L W Lee; G N Hortobagyi Journal: J Clin Oncol Date: 1999-05 Impact factor: 44.544
Authors: Christine E Swenson; Lois E Bolcsak; Gerald Batist; Troy H Guthrie; Katherine H Tkaczuk; Harold Boxenbaum; Lauri Welles; Shein-Chung Chow; Rupinder Bhamra; Philip Chaikin Journal: Anticancer Drugs Date: 2003-03 Impact factor: 2.248