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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00014313
Recruitment Status : Terminated (low accrual)
First Posted : January 27, 2003
Last Update Posted : September 24, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief 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 II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic Ewing's sarcoma or primitive neuroectodermal tumor.

Condition or disease Intervention/treatment Phase
Sarcoma Drug: cisplatin Drug: etoposide Phase 2

Detailed Description:


  • 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  (Clinical Trial)
Actual Enrollment : 3 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study to Evaluate the Role of Weekly Cisplatin With Oral Etoposide in Ewing's Sarcoma and Primitive Neuroectodermal Tumor (PNET) With Bone and/or Bone Marrow Metatstatic Disease
Study Start Date : January 2001
Actual Primary Completion Date : December 2002

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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 15 to 65

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified


  • WBC at least 3,000/mm3
  • Neutrophil count at least 2,000/mm3
  • Platelet count at least 100,000/mm3


  • Bilirubin less than 3 mg/dL
  • Albumin greater than 2.5 g/dL


  • Creatinine less than 1.2 mg/dL
  • Creatinine clearance greater than 70 mL/min


  • No history of uncontrolled cardiovascular disease


  • 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


Biologic therapy:

  • Not specified


  • No prior chemotherapy

Endocrine therapy:

  • Not specified


  • See Disease Characteristics


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00014313

United Kingdom
Institute of Cancer Research - UK
Sutton, England, United Kingdom, SM2 5NG
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Study Chair: Ian R. Judson, MA, MD, FRCP Institute of Cancer Research, United Kingdom

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00014313     History of Changes
Other Study ID Numbers: EORTC-62993
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: September 24, 2012
Last Verified: September 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor

Additional relevant MeSH terms:
Sarcoma, Ewing
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial
Etoposide phosphate
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action