Liposomal Doxorubicin Plus Ifosfamide in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining liposomal doxorubicin with ifosfamide in treating patients who have advanced or metastatic soft tissue sarcoma.
|Sarcoma||Drug: ifosfamide Drug: pegylated liposomal doxorubicin hydrochloride||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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|
|Study Start Date:||November 2001|
|Primary Completion Date:||March 2005 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00030784
|Aarhus University Hospital - Aarhus Sygehus - Norrebrogade|
|Aarhus, Denmark, DK-8000|
|Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch|
|Berlin, Germany, D-13122|
|Study Chair:||Ole S. Nielsen, MD||Aarhus Universitetshospital - Aarhus Sygehus|