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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining liposomal doxorubicin with ifosfamide in treating patients who have advanced or metastatic soft tissue sarcoma.

• Phase: Phase 1
• 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

• Advanced and/or metastatic disease

• Must be of any of the following types:

• Malignant fibrous histiocytoma

• Liposarcoma (excluding lipomas and well-differentiated liposarcomas)

• Rhabdomyosarcoma

• Synovial sarcoma

• Malignant paraganglioma

• Fibrosarcoma

• Leiomyosarcoma

• Angiosarcoma

• Neurogenic sarcoma

• Sarcoma not otherwise specified

• Paraffin blocks and slides must be available

• Measurable disease

• Osseous lesions and pleural effusions are not considered measurable disease

• Evidence of progressive disease within the past 6 weeks

• The following conditions are excluded:

• Gastrointestinal stromal tumors

• Malignant mesothelioma

• Chondrosarcoma

• Neuroblastoma

• Osteosarcoma

• Ewing's sarcoma

• Embryonal rhabdomyosarcoma

• No symptomatic or known CNS metastases

PATIENT CHARACTERISTICS:

Age:

• 18 to 70

Performance status:

• WHO 0-1

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 4,000/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.75 mg/dL

• Albumin at least 2.5 g/dL

Renal:

• Creatinine no greater than 1.4 mg/dL

• Creatinine clearance at least 65 mL/min

Cardiovascular:

• Ejection fraction at least 50% by echocardiogram or isotopic methods

• No history of cardiovascular disease

Other:

• No other prior or concurrent primary malignancies except adequately treated carcinoma in situ of the cervix or basal cell carcinoma

• No other severe medical illness

• No psychosis

• No psychological, familial, sociological, or geographical condition that would preclude study participation

• Not pregnant

• Fertile patients must use effective contraception (barrier method for men) during and for 6 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy for advanced disease

• No other concurrent systemic chemotherapy for malignancy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy to sole indicator lesion

• Concurrent radiotherapy allowed except to sole indicator lesion

Surgery:

• Not specified

Other:

• No other concurrent investigational drugs