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

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Doxorubicin; Ifosfamide; Isophosphamide mustard; Liposomal doxorubicin

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