Trial Information

Randomized Phase III Trial of Two Investigational Schedules of Ifosfamide vs. Standard Dose Doxorubicin in Patients With Advanced or Metastatic Soft Tissue Sarcoma

OBJECTIVES: I. Determine the progression free survival rate in patients with advanced or
metastatic soft tissue sarcoma treated with either of two different regimens of ifosfamide
or doxorubicin. II. Assess the toxic effects of these therapies and response rate in these
patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized into one of 3 arms
(continuous ifosfamide, ifosfamide daily for 3 days, or doxorubicin). Patients are
stratified by performance status (0 vs 1), liver involvement (no vs yes), histological type
(leiomyosarcoma vs synovial sarcoma vs other), and histological grade (1 vs 2 vs 3). Arm I:
Patients receive doxorubicin by bolus infusion for 5-20 minutes once every 3 weeks. Arm II:
Patients receive ifosfamide by intravenous infusion for 4 hours on days 1, 2, and 3 every
three weeks. Arm III: Patients receive ifosfamide by intravenous infusion for 72 hours every
3 weeks. Patients are assessed after every 2 courses of therapy. Each course of therapy
consists of 3 weeks of treatment. Patients may receive a maximum of 6 courses of therapy in
the absence of toxicity and disease progression. Patients are followed every 12 weeks for
survival.

PROJECTED ACCRUAL: A total of 780 patients (260 per treatment arm) will be accrued for this
study.