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Trial record 19 of 23 for:    "Undifferentiated Pleomorphic Sarcoma" | "Antibiotics, Antitubercular"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003212
Recruitment Status : Completed
First Posted : March 12, 2004
Last Update Posted : January 20, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 1998
Actual Primary Completion Date : November 2001

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003212

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Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Aarhus Kommunehospital
Aarhus, Denmark, DK-8000
Copenhagen, Denmark, 2100
Centre Leon Berard
Lyon, France, 69373
Institut Gustave Roussy
Villejuif, France, F-94805
Medizinische Hochschule Hannover
Hannover, Germany, D-30625
Klinikum Grosshadern
Munich, Germany, D-81377
National Institute of Oncology
Budapest, Hungary, 1125
Antoni van Leeuwenhoekhuis
Amsterdam, Netherlands, 1066 CX
Leiden University Medical Center
Leiden, Netherlands, 2300 CA
University Medical Center Nijmegen
Nijmegen, Netherlands, NL-6252 HB
Rotterdam Cancer Institute
Rotterdam, Netherlands, 3075 EA
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, Poland, 02-781
National Cancer Institute - Bratislava
Bratislava, Slovakia, 833 10
Hospital Insular de Gran Canaria
Las Palmas, Spain, G.C.
United Kingdom
St. James's Hospital
Leeds, England, United Kingdom, LS9 7TF
Royal Marsden NHS Trust
London, England, United Kingdom, SW3 6JJ
Middlesex Hospital- Meyerstein Institute
London, England, United Kingdom, WIT 3AA
Christie Hospital N.H.S. Trust
Manchester, England, United Kingdom, M20 4BX
Newcastle General Hospital
Newcastle Upon Tyne, England, United Kingdom, NE4 6BE
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom, NG5 1PB
Weston Park Hospital
Sheffield, England, United Kingdom, S1O 2SJ
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
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Study Chair: Paul C. Lorigan, MD The Christie NHS Foundation Trust

Publications of Results:
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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00003212     History of Changes
Other Study ID Numbers: EORTC-62971
First Posted: March 12, 2004    Key Record Dates
Last Update Posted: January 20, 2012
Last Verified: January 2012
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
adult malignant fibrous histiocytoma
adult angiosarcoma
adult fibrosarcoma
adult leiomyosarcoma
adult liposarcoma
adult neurofibrosarcoma
adult synovial sarcoma
recurrent adult soft tissue sarcoma
adult malignant hemangiopericytoma
adult rhabdomyosarcoma
stage IV uterine sarcoma
recurrent uterine sarcoma
stage IV adult soft tissue sarcoma
Additional relevant MeSH terms:
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Antibiotics, Antineoplastic
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Liposomal doxorubicin
Isophosphamide mustard
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents