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

NCT ID: NCT00014313

Last Updated: 2012-09-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-01-31

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.

Detailed Description

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.

Conditions

Sarcoma

Keywords

metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

cisplatin

Intervention Type: DRUG

etoposide

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ian R. Judson, MA, MD, FRCP

Role: STUDY_CHAIR

Institute of Cancer Research, United Kingdom

Locations

Institute of Cancer Research - UK

Sutton, England, United Kingdom

Countries

United Kingdom

Other Identifiers

EORTC-62993

Identifier Type: -

Identifier Source: secondary_id

EORTC-62993

Identifier Type: -

Identifier Source: org_study_id