Doxorubicin With or Without Ifosfamide and Pegfilgrastim in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma - Full Text View

Sponsored by:	European Organization for Research and Treatment of Cancer
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00061984

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control
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:

MedlinePlus related topics: Cancer Soft Tissue Sarcoma

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Myocet Pegfilgrastim Ifosfamide

U.S. FDA Resources

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

Detailed Description:

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

Show 39 Study Locations

Sponsors and Collaborators

European Organization for Research and Treatment of Cancer

Investigators

Investigator:

Ian R. Judson, MA, MD, FRCP

Institute of Cancer Research, United Kingdom

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000302584, EORTC-62012
Study First Received:	June 5, 2003
Last Updated:	June 16, 2009
ClinicalTrials.gov Identifier:	NCT00061984 History of Changes
Health Authority:	Unspecified

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

Study placed in the following topic categories:

Histiocytoma, Malignant Fibrous
Fibrosarcoma
Leiomyosarcoma
Histiocytoma, Benign Fibrous
Hemangiosarcoma
Doxorubicin
Malignant Fibrous Histiocytoma
Sarcoma, Synovial
Anti-Bacterial Agents
Neoplasms, Connective and Soft Tissue
Ifosfamide
Liposarcoma

Malignant Mesenchymal Tumor
Soft Tissue Sarcomas
Histiocytoma
Epithelioid Sarcoma
Mechlorethamine
Sarcoma
Synovial Sarcoma
Antineoplastic Agents, Alkylating
Alkylating Agents
Isophosphamide mustard
Rhabdomyosarcoma

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on July 02, 2009