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

NCT00003212 | Completed Phase 3

• 1 other identifier: EORTC-62971
• Study Type: interventional
• Target: 780
• Locations: 10 countries
• Sites: 23

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.

Conditions

Sarcoma

Keywords

adult angiosarcoma; adult fibrosarcoma; adult leiomyosarcoma; adult liposarcoma; adult neurofibrosarcoma; adult synovial sarcoma; recurrent adult soft tissue sarcoma; adult malignant fibrous histiocytoma; adult malignant hemangiopericytoma; adult rhabdomyosarcoma; stage IV uterine sarcoma; recurrent uterine sarcoma; stage IV adult soft tissue sarcoma

Interventions

doxorubicin hydrochloride DRUG

ifosfamide DRUG

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (23)

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Aarhus Kommunehospital

Aarhus, DK-8000, Denmark

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Centre Leon Berard

Lyon, 69373, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Medizinische Hochschule Hannover

Hanover, D-30625, Germany

Location

Klinikum Grosshadern

Munich, D-81377, Germany

Location

National Institute of Oncology

Budapest, 1125, Hungary

Location

Antoni van Leeuwenhoekhuis

Amsterdam, 1066 CX, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 CA, Netherlands

Location

University Medical Center Nijmegen

Nijmegen, NL-6252 HB, Netherlands

Location

Rotterdam Cancer Institute

Rotterdam, 3075 EA, Netherlands

Location

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

Warsaw, 02-781, Poland

Location

National Cancer Institute - Bratislava

Bratislava, 833 10, Slovakia

Location

Hospital Insular de Gran Canaria

Las Palmas, G.C., Spain

Location

St. James's Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Royal Marsden NHS Trust

London, England, SW3 6JJ, United Kingdom

Location

Middlesex Hospital- Meyerstein Institute

London, England, WIT 3AA, United Kingdom

Location

Christie Hospital N.H.S. Trust

Manchester, England, M20 4BX, United Kingdom

Location

Newcastle General Hospital

Newcastle upon Tyne, England, NE4 6BE, United Kingdom

Location

Nottingham City Hospital NHS Trust

Nottingham, England, NG5 1PB, United Kingdom

Location

Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

Related Publications (1)

• Lorigan P, Verweij J, Papai Z, Rodenhuis S, Le Cesne A, Leahy MG, Radford JA, Van Glabbeke MM, Kirkpatrick A, Hogendoorn PC, Blay JY; European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group Study. Phase III trial of two investigational schedules of ifosfamide compared with standard-dose doxorubicin in advanced or metastatic soft tissue sarcoma: a European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group Study. J Clin Oncol. 2007 Jul 20;25(21):3144-50. doi: 10.1200/JCO.2006.09.7717.

  PMID: 17634494 RESULT

MeSH Terms

Conditions

Sarcoma; Hemangiosarcoma; Fibrosarcoma; Leiomyosarcoma; Liposarcoma; Neurofibrosarcoma; Sarcoma, Synovial; Histiocytoma, Malignant Fibrous; Hemangiopericytoma, Malignant; Rhabdomyosarcoma

Interventions

Doxorubicin; Ifosfamide

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Neoplasms, Adipose Tissue; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Peripheral Nervous System Neoplasms; Nervous System Neoplasms; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Histiocytoma; Myosarcoma

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Paul C. Lorigan, MD

  The Christie NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: March 12, 2004
• Study Start: January 1, 1998
• Primary Completion: November 1, 2001
• Last Updated: January 20, 2012

Record last verified: 2012-01

Locations

DE (2); SL (1); ES (1); GB (7); HU (1); NL (4); FR (2); DK (2); BE (2); PL (1)