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

Sarcoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00014313
• Other study ID #: EORTC-62993
• Secondary ID: EORTC-62993
• Status: Terminated
• Phase: Phase 2
• First received: April 10, 2001
• Last updated: September 20, 2012
• Start date: January 2001

Study information

• Verified date: September 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. primary completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 65 Years

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuroectodermal Tumors
• Neuroectodermal Tumors, Primitive
• Sarcoma
• Sarcoma, Ewing

Intervention

Drug:
• cisplatin

• etoposide

Locations

Country	Name	City	State
United Kingdom	Institute of Cancer Research - UK	Sutton	England

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Country where clinical trial is conducted

United Kingdom,