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

European Organisation for Research and Treatment of Cancer - EORTC28 enrolled

Overview

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.

OBJECTIVES: * Determine the maximum tolerated dose of ifosfamide in combination with doxorubicin HCl liposome in patients with previously untreated advanced or metastatic soft tissue sarcoma. * Determine the objective response in patients treated with this regimen. * Determine the dose-limiting toxicity in patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of ifosfamide. Patients receive doxorubicin HCl liposome IV over 1 hour on day 1 and ifosfamide IV over 4 hours on days 1-3 OR on days 1-4 (for patients enrolled on dose level 6). Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of ifosfamide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 8 weeks until disease progression and then every 12 weeks thereafter. PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Sarcoma

Interventions

ifosfamideDRUG

pegylated liposomal doxorubicin hydrochlorideDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (2)

Aarhus University Hospital - Aarhus Sygehus - Norrebrogade

Aarhus, Denmark

Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch

Berlin, Germany

Data from ClinicalTrials.gov

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