Doxorubicin With or Without Ifosfamide and Pegfilgrastim in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00061984
First received: June 5, 2003
Last updated: May 21, 2010
Last verified: July 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: Drugs used in chemotherapy such as doxorubicin and ifosfamide use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors, such as pegfilgrastim, cause the body to make blood cells. It is not yet known whether doxorubicin alone is more effective with or without ifosfamide and pegfilgrastim in treating soft tissue sarcoma.
PURPOSE: This randomized phase III trial is studying giving doxorubicin alone to see how well it works compared to giving doxorubicin together with ifosfamide and pegfilgrastim in treating patients with locally advanced or metastatic soft tissue sarcoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma |
Biological: pegfilgrastim Drug: doxorubicin hydrochloride Drug: ifosfamide Procedure: multimodality therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomised Trial Of Single Agent Doxorubicin Versus Doxorubicin Plus Ifosfamide In The First Line Treatment Of Advanced Or Metastatic Soft Tissue Sarcoma |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Overall survival [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Response as assessed by RECIST criteria [ Designated as safety issue: No ]
- Toxicity as assessed by CTC 2.0 [ Designated as safety issue: Yes ]
- Treatment-related mortality [ Designated as safety issue: No ]
| Estimated Enrollment: | 450 |
| Study Start Date: | April 2003 |
OBJECTIVES:
- Compare the progression-free and overall survival of patients with locally advanced or metastatic soft tissue sarcoma treated with doxorubicin with vs without ifosfamide and pegfilgrastim as first-line therapy.
- Compare the response in patients treated with these regimens.
- Compare the treatment-related mortality of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to WHO performance status (0 vs 1), age group (less than 50 years of age vs 50 years of age and over), presence of liver metastases (yes vs no), histological grade (2 vs 3), and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive doxorubicin IV on day 1 (or IV continuously on days 1-3).
- Arm II: Patients receive doxorubicin IV on days 1-3 and ifosfamide IV over 4 hours on days 1-4. Patients also receive pegfilgrastim subcutaneously on day 5.
In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 8 weeks until disease progression and then every 12 weeks thereafter.
PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study within 4 years.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed soft tissue sarcoma
- Locally advanced unresectable* OR metastatic disease
- High-grade (grade 2-3) disease according to the FNLCC grading system NOTE: *Disease that could prove resectable (including pulmonary metastasectomy) after a response to chemotherapy is allowed
The following tumor types are eligible:
- Malignant fibrous histiocytoma
- Myxoid and round cell liposarcoma, pleomorphic liposarcoma, or dedifferentiated liposarcoma
- Pleomorphic rhabdomyosarcoma
- Synovial sarcoma
- Myxofibrosarcoma, intermediate and high-grade
- Fibrosarcoma
- Leiomyosarcoma
- Angiosarcoma
- Malignant peripheral nerve sheath tumor
- Epithelioid sarcoma
- Alveolar rhabdomyosarcoma
- Unclassifiable sarcoma, not otherwise specified
The following tumor types are not eligible:
- Gastrointestinal stromal tumor
- Mixed mesodermal tumor
- Chondrosarcoma
- Malignant mesothelioma
- Neuroblastoma
- Osteosarcoma
- Ewing's sarcoma/primitive neuroectodermal tumor
- Desmoplastic small round cell tumor
- Embryonal rhabdomyosarcoma
- Alveolar soft part sarcoma
Must have a measurable lesion with clinical evidence of progression within the past 6 weeks
- Osseous lesions and pleural effusions are not considered measurable
- No known or symptomatic CNS metastases
PATIENT CHARACTERISTICS:
Age
- 18 to 60
Performance status
- WHO 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.8 mg/dL
- Albumin at least 2.5 g/dL
Renal
- Creatinine no greater than 1.4 mg/dL OR
- Creatinine clearance greater than 65 mL/min
Cardiovascular
- No history of cardiovascular disease
Other
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other severe medical illness
- No psychosis
- No other prior or concurrent malignancy except adequately treated carcinoma in situ of the cervix or basal cell skin cancer
- No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up schedule
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy for advanced or metastatic disease
- Prior adjuvant chemotherapy allowed provided there was no disease progression within 6 months after completion of treatment
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy to the sole index lesion
Surgery
- Not specified
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00061984
Hide Study Locations
Hide Study LocationsLocations
| Austria | |
| Karl-Franzens-University Graz | |
| Graz, Austria, A-8010 | |
| Belgium | |
| Institut Jules Bordet | |
| Brussels, Belgium, 1000 | |
| Universitair Ziekenhuis Antwerpen | |
| Edegem, Belgium, B-2650 | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| Canada, Alberta | |
| Tom Baker Cancer Centre - Calgary | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Cross Cancer Institute at University of Alberta | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, Newfoundland and Labrador | |
| Doctor H. Bliss Murphy Cancer Centre | |
| St. John's, Newfoundland and Labrador, Canada, A1B 3V6 | |
| Canada, Ontario | |
| Margaret and Charles Juravinski Cancer Centre | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Canada, Quebec | |
| McGill Cancer Centre at McGill University | |
| Montreal, Quebec, Canada, H3G 1Y6 | |
| Denmark | |
| Aarhus Universitetshospital - Aarhus Sygehus | |
| Aarhus, Denmark, DK-8000 | |
| Copenhagen County Herlev University Hospital | |
| Copenhagen, Denmark, DK-2730 | |
| France | |
| Institut Bergonie | |
| Bordeaux, France, 33076 | |
| Centre Leon Berard | |
| Lyon, France, 69373 | |
| CHU de la Timone | |
| Marseille, France, 13385 | |
| Germany | |
| Medizinische Universitaetsklinik I at the University of Cologne | |
| Cologne, Germany, D-50924 | |
| Universitatsklinikum Carl Gustav Carus | |
| Dresden, Germany, D-01307 | |
| Universitaetsklinikum Essen | |
| Essen, Germany, D-45122 | |
| Medizinische Hochschule Hannover | |
| Hannover, Germany, D-30625 | |
| Klinikum der Stadt Mannheim | |
| Mannheim, Germany, D-68135 | |
| Klinikum der Universitaet Muenchen - Grosshadern Campus | |
| Munich, Germany, D-81377 | |
| Southwest German Cancer Center at Eberhard-Karls-University | |
| Tuebingen, Germany, D-72076 | |
| Netherlands | |
| Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital | |
| Amsterdam, Netherlands, 1066 CX | |
| University Medical Center Groningen | |
| Groningen, Netherlands, 9700 RB | |
| Leiden University Medical Center | |
| Leiden, Netherlands, 2300 CA | |
| Universitair Medisch Centrum St. Radboud - Nijmegen | |
| Nijmegen, Netherlands, NL-6500 HB | |
| University Medical Center Rotterdam at Erasmus Medical Center | |
| Rotterdam, Netherlands, 3000 CA | |
| Slovakia | |
| National Cancer Institute - Bratislava | |
| Bratislava, Slovakia, 833 10 | |
| Spain | |
| Vall d'Hebron University Hospital | |
| Barcelona, Spain, 08035 | |
| Hospital Universitario San Carlos | |
| Madrid, Spain, 28040 | |
| Switzerland | |
| Centre Hospitalier Universitaire Vaudois | |
| Lausanne, Switzerland, CH-1011 | |
| United Kingdom | |
| Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust | |
| Birmingham, England, United Kingdom, B15 2TH | |
| Leeds Cancer Centre at St. James's University Hospital | |
| Leeds, England, United Kingdom, LS9 7TF | |
| University College of London Hospitals | |
| London, England, United Kingdom, WIT 3AA | |
| Royal Marsden - London | |
| London, England, United Kingdom, SW3 6JJ | |
| Northern Centre for Cancer Treatment at Newcastle General Hospital | |
| Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE | |
| Derriford Hospital | |
| Plymouth, England, United Kingdom, PL6 8DH | |
| Cancer Research Centre at Weston Park Hospital | |
| Sheffield, England, United Kingdom, S1O 2SJ | |
| Aberdeen Royal Infirmary | |
| Aberdeen, Scotland, United Kingdom, AB25 2ZN | |
| Edinburgh Cancer Centre at Western General Hospital | |
| Edinburgh, Scotland, United Kingdom, EH4 2XU | |
| Gartnavel General Hospital | |
| Glasgow, Scotland, United Kingdom, G12 0YN | |
| Western Infirmary | |
| Glasgow, Scotland, United Kingdom, G11 6NT | |
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
| Investigator: | Ian R. Judson, MA, MD, FRCP | Institute of Cancer Research, United Kingdom |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00061984 History of Changes |
| Other Study ID Numbers: | CDR0000302584, EORTC-62012 |
| Study First Received: | June 5, 2003 |
| Last Updated: | May 21, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adult angiosarcoma adult epithelioid sarcoma adult fibrosarcoma adult leiomyosarcoma adult liposarcoma adult rhabdomyosarcoma |
adult synovial sarcoma stage III adult soft tissue sarcoma adult malignant fibrous histiocytoma adult neurofibrosarcoma stage II adult soft tissue sarcoma stage IV adult soft tissue sarcoma |
Additional relevant MeSH terms:
|
Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Doxorubicin Isophosphamide mustard Ifosfamide |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013