Ifosfamide or Doxorubicin in Treating Patients With Advanced or Metastatic Soft Tissue Sarcoma

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC (Other)

Overall Status

Completed

CT.gov ID

NCT00003212

Collaborator

(none)

780

Enrollment

Locations

33.9

Patients Per Site

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether ifosfamide or doxorubicin is more effective for advanced or metastatic soft tissue sarcoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of ifosfamide with that of doxorubicin in treating patients who have advanced or metastatic soft tissue sarcoma.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma	Drug: doxorubicin hydrochloride Drug: ifosfamide	Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

780 participants

Allocation:

Randomized

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 1998

Actual Primary Completion Date :

Nov 1, 2001

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS: Histologically proven advanced or metastatic soft tissue sarcoma including the following: Malignant fibrous histiocytoma Liposarcoma Rhabdomyosarcoma Synovial sarcoma Malignant paraganglioma Fibrosarcoma Leiomyosarcoma Angiosarcoma including haemangiopericytoma Neurogenic sarcoma Unclassified sarcoma Mixed mesodermal tumor of the uterus Measurable disease with evidence of progression in prior 6 weeks No symptomatic or known CNS metastases

PATIENT CHARACTERISTICS: Age: 15 to 65 Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3000/mm3 Neutrophil count greater than 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater 1.75 mg/dL Albumin at least 25 g/L Renal: Creatinine clearance greater than 70 mL/min Cardiovascular: No history of uncontrolled cardiovascular disease Other: Fertile women must use effective contraception No other severe medical illness including psychosis No prior primary malignant tumor except: Adequately treated carcinoma in situ of the cervix Basal cell carcinoma

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No radiotherapy to the sole index lesion Surgery: Not specified

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitair Ziekenhuis Antwerpen	Edegem		Belgium	B-2650
2	U.Z. Gasthuisberg	Leuven		Belgium	B-3000
3	Aarhus Kommunehospital	Aarhus		Denmark	DK-8000
4	Rigshospitalet	Copenhagen		Denmark	2100
5	Centre Leon Berard	Lyon		France	69373
6	Institut Gustave Roussy	Villejuif		France	F-94805
7	Medizinische Hochschule Hannover	Hannover		Germany	D-30625
8	Klinikum Grosshadern	Munich		Germany	D-81377
9	National Institute of Oncology	Budapest		Hungary	1125
10	Antoni van Leeuwenhoekhuis	Amsterdam		Netherlands	1066 CX
11	Leiden University Medical Center	Leiden		Netherlands	2300 CA
12	University Medical Center Nijmegen	Nijmegen		Netherlands	NL-6252 HB
13	Rotterdam Cancer Institute	Rotterdam		Netherlands	3075 EA
14	Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology	Warsaw		Poland	02-781
15	National Cancer Institute - Bratislava	Bratislava		Slovakia	833 10
16	Hospital Insular de Gran Canaria	Las Palmas		Spain	G.C.
17	St. James's Hospital	Leeds	England	United Kingdom	LS9 7TF
18	Royal Marsden NHS Trust	London	England	United Kingdom	SW3 6JJ
19	Middlesex Hospital- Meyerstein Institute	London	England	United Kingdom	WIT 3AA
20	Christie Hospital N.H.S. Trust	Manchester	England	United Kingdom	M20 4BX
21	Newcastle General Hospital	Newcastle Upon Tyne	England	United Kingdom	NE4 6BE
22	Nottingham City Hospital NHS Trust	Nottingham	England	United Kingdom	NG5 1PB
23	Weston Park Hospital	Sheffield	England	United Kingdom	S1O 2SJ