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

Primary Purpose

Sarcoma

Status
Terminated
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
cisplatin
etoposide
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Cancer Research - UK

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 10, 2001
Last Updated
September 20, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00014313
Brief Title
Chemotherapy in Treating Patients With Metastatic Ewing's Sarcoma or Primitive Neuroectodermal Tumor
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 Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Terminated
Why Stopped
low accrual
Study Start Date
January 2001 (undefined)
Primary Completion Date
December 2002 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
etoposide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian R. Judson, MA, MD, FRCP
Organizational Affiliation
Institute of Cancer Research, United Kingdom
Official's Role
Study Chair
Facility Information:
Facility Name
Institute of Cancer Research - UK
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5NG
Country
United Kingdom

12. IPD Sharing Statement

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

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