Medpedia

• Sarcoma

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

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.

• Drug: cisplatin
• Drug: etoposide

• Ian R. Judson, MA, MD, FRCP
  Study Chair, Institute of Cancer Research, United Kingdom

• Institute of Cancer Research - UK
  Sutton, England, SM2 5NG, United Kingdom
  Active, not recruiting

• European Organization for Research and Treatment of Cancer
  Lead Sponsor
• United States: Federal Government

• Clinical trial summary from the National Cancer Institute's PDQ® database
  http://cancer.gov/clinicaltrials/EORTC-62993