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| Sponsored by: |
European Organization for Research and Treatment of Cancer |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003212 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Sarcoma |
Drug: doxorubicin hydrochloride Drug: ifosfamide |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| 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 |
| Estimated Enrollment: | 780 |
| Study Start Date: | January 1998 |
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.
Eligibility| Ages Eligible for Study: | 15 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histolgically 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| Belgium | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| Universitair Ziekenhuis Antwerpen | |
| Edegem, Belgium, B-2650 | |
| Denmark | |
| Aarhus Kommunehospital | |
| Aarhus, Denmark, DK-8000 | |
| Rigshospitalet | |
| Copenhagen, Denmark, 2100 | |
| France | |
| Centre Leon Berard | |
| Lyon, France, 69373 | |
| Institut Gustave Roussy | |
| Villejuif, France, F-94805 | |
| Germany | |
| Klinikum Grosshadern | |
| Munich, Germany, D-81377 | |
| Medizinische Hochschule Hannover | |
| Hannover, Germany, D-30625 | |
| Hungary | |
| National Institute of Oncology | |
| Budapest, Hungary, 1125 | |
| Netherlands | |
| Antoni van Leeuwenhoekhuis | |
| Amsterdam, Netherlands, 1066 CX | |
| Leiden University Medical Center | |
| Leiden, Netherlands, 2300 CA | |
| Rotterdam Cancer Institute | |
| Rotterdam, Netherlands, 3075 EA | |
| University Medical Center Nijmegen | |
| Nijmegen, Netherlands, NL-6252 HB | |
| Poland | |
| Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology | |
| Warsaw, Poland, 02-781 | |
| Slovakia | |
| National Cancer Institute - Bratislava | |
| Bratislava, Slovakia, 833 10 | |
| Spain | |
| Hospital Insular de Gran Canaria | |
| Las Palmas, Spain, G.C. | |
| United Kingdom, England | |
| Christie Hospital N.H.S. Trust | |
| Manchester, England, United Kingdom, M20 4BX | |
| Weston Park Hospital | |
| Sheffield, England, United Kingdom, S1O 2SJ | |
| Newcastle General Hospital | |
| Newcastle Upon Tyne, England, United Kingdom, NE4 6BE | |
| Nottingham City Hospital NHS Trust | |
| Nottingham, England, United Kingdom, NG5 1PB | |
| Royal Marsden NHS Trust | |
| London, England, United Kingdom, SW3 6JJ | |
| St. James's Hospital | |
| Leeds, England, United Kingdom, LS9 7TF | |
| Middlesex Hospital- Meyerstein Institute | |
| London, England, United Kingdom, WIT 3AA | |
| Study Chair: | Paul C. Lorigan, MD | Christie Hospital NHS Foundation Trust |
More Information
| Study ID Numbers: | CDR0000066070, EORTC-62971 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003212 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
|
Fibrosarcoma Histiocytoma, Malignant Fibrous Histiocytoma, Benign Fibrous Leiomyosarcoma Sarcoma, Synovial Malignant Fibrous Histiocytoma Neoplasms, Connective and Soft Tissue Anti-Bacterial Agents Soft Tissue Sarcomas Synovial Sarcoma Alkylating Agents Rhabdomyosarcoma Hemangiosarcoma |
Hemangiopericytoma Recurrence Doxorubicin Liposarcoma Malignant Mesenchymal Tumor Ifosfamide Histiocytoma Uterine Sarcoma Mechlorethamine Sarcoma Antineoplastic Agents, Alkylating Isophosphamide mustard |
|
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antibiotics, Antineoplastic Doxorubicin Pharmacologic Actions Neoplasms, Connective and Soft Tissue |
Neoplasms Ifosfamide Therapeutic Uses Sarcoma Antineoplastic Agents, Alkylating Alkylating Agents Isophosphamide mustard |
