Chemotherapy in Treating Patients With Metastatic Ewing's Sarcoma or Primitive Neuroectodermal Tumor

Phase 2TerminatedNCT00014313

European Organisation for Research and Treatment of Cancer - EORTC3 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 II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic Ewing's sarcoma or primitive neuroectodermal tumor.

OBJECTIVES: * Determine the activity of cisplatin and etoposide in terms of response of patients with metastatic Ewing's sarcoma or primitive neuroectodermal tumor. * Assess the bone marrow and kidney toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive cisplatin IV over 3 hours on days 1, 8, 15, 29, 36, and 43 and oral etoposide daily on days 1-15 and 29-43 in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study within 2 years.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sarcoma

Interventions

cisplatinDRUG

etoposideDRUG

Eligibility

Sex: ALLMin age: 15 YearsMax age: 65 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically confirmed Ewing's family tumor as characterized by the following: * Positive MIC2 on immunohistochemistry OR * Evidence of a chromosomal translocation involving the EWS gene by conventional cytogenetics * t(11; 22) translocation or variant OR * Demonstration of EWS/FLI1 or EWS/ERG gene fusion by PCR or FISH * Metastases outside the lung or pleura * At least 1 measurable lesion outside of previously irradiated area * No symptomatic or known CNS metastases PATIENT CHARACTERISTICS: Age: * 15 to 65 Performance status: * WHO 0-2 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm3 * Neutrophil count at least 2,000/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin less than 3 mg/dL * Albumin greater than 2.5 g/dL Renal: * Creatinine less than 1.2 mg/dL * Creatinine clearance greater than 70 mL/min Cardiovascular: * No history of uncontrolled cardiovascular disease Other: * No other severe medical illness, including psychosis * No other prior primary malignancy except adequately treated carcinoma in situ of the cervix or basal cell skin cancer * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics Surgery: * Not specified

Locations (1)

Institute of Cancer Research - UK

Sutton, England, United Kingdom

Data from ClinicalTrials.gov

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