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. It is not yet known whether surgery plus combination chemotherapy is more effective than surgery alone in treating patients with lung metastases from soft tissue sarcoma. PURPOSE: Randomized phase III trial to compare the effectiveness of surgery plus combination chemotherapy with that of surgery alone in treating patients who have soft tissue sarcoma that has spread to the lung.

OBJECTIVES: I. Compare disease control, overall survival, and relapse-free survival in patients with lung metastases secondary to soft tissue sarcoma treated with high-dose doxorubicin and ifosfamide with or without filgrastim (G-CSF) before and after metastasectomy vs metastasectomy alone. II. Determine the safety and morbidity of this regimen in these patients.

PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to location of metastases (unilateral vs bilateral). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients are assigned to regimen A or B. Regimen A: Patients receive high-dose doxorubicin IV and ifosfamide IV continuously on day 1 and filgrastim (G-CSF) subcutaneously on days 3-13. Regimen B: Patients receive chemotherapy as above without G-CSF. Treatment on both regimens continues every 3 weeks for 3 courses. Patients then undergo radical pulmonary metastasectomy via thoracotomy or sternotomy with wedge resection or lobectomy. Patients with responding disease after metastasectomy receive 2 additional courses on the regimen to which they were originally assigned. Arm II: Patients undergo radical pulmonary metastasectomy as in arm I. Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 340 patients (170 per treatment arm) will be accrued for this study within approximately 4.5 years.

Ages Eligible for Study:  16 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven soft tissue sarcoma with pulmonary metastases for which radical metastasectomy is feasible
• Eligible subtypes: Malignant fibrous histiocytoma; Liposarcoma; Synovial sarcoma; Malignant paraganglioma; Fibrosarcoma; Leiomyosarcoma; Neurogenic sarcoma; Unclassified sarcoma; Angiosarcoma (including hemangiopericytoma); Miscellaneous sarcoma (including mixed mesodermal tumors of the uterus)
• Ineligible subtypes: Alveolar rhabdomyosarcoma; Kaposi's sarcoma; Rhabdomyosarcoma of any type; Malignant mesothelioma; Chondrosarcoma; Neuroblastoma; Dermatofibrosarcoma; Osteosarcoma; Epithelioid sarcoma; Primitive neuroectodermal tumor; Ewing's sarcoma
• No extrapulmonary disease
• Previously treated local recurrence allowed
• Patients with primarily metastatic disease must have undergone radical treatment of primary tumor according to local protocols; Reevaluation of metastases required before randomization

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: No prior chemotherapy for metastatic disease; Prior neoadjuvant or adjuvant chemotherapy for primary soft tissue sarcoma allowed if cumulative dose of doxorubicin no greater than 200 mg/m2; At least 1 year since prior chemotherapy
• Endocrine therapy: Not specified
• Radiotherapy: Not specified
• Surgery: See Disease Characteristics

--Patient Characteristics--

• Age: 16 and over
• Performance status: WHO 0-1
• Life expectancy: Not specified
• Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 120,000/mm3
• Hepatic: Bilirubin no greater than 1.25 times normal
• Renal: Creatinine no greater than 1.6 mg/dL OR Creatinine clearance at least 60 mL/min
• Cardiovascular: No history of cardiovascular disease
• Other: No other severe medical illness (including psychosis); No prior or concurrent other primary malignancy except adequately treated carcinoma in situ of the cervix or basal cell carcinoma