Phase I Study To Determine The Safety Of Caelyx (Doxorubin HCI, Pegylated Liposomal) In Combination With Ifosfamide In Previously Untreated Adult Patients With Advanced And/Or Metastatic Soft Tissues Sarcomas
OBJECTIVES:
- Determine the maximum tolerated dose of ifosfamide in combination with doxorubicin HCl
liposome in patients with previously untreated advanced or metastatic soft tissue
sarcoma.
- Determine the objective response in patients treated with this regimen.
- Determine the dose-limiting toxicity in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of ifosfamide.
Patients receive doxorubicin HCl liposome IV over 1 hour on day 1 and ifosfamide IV over 4
hours on days 1-3 OR on days 1-4 (for patients enrolled on dose level 6). Treatment repeats
every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable
toxicity.
Cohorts of 3-6 patients receive escalating doses of ifosfamide until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2
of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 8 weeks until disease progression and then every 12 weeks
thereafter.
PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Ole S. Nielsen, MD
Study Chair
Aarhus Universitetshospital - Aarhus Sygehus
United States: Federal Government
EORTC-62002
NCT00030784
November 2001
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