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

NCT00014313 | Terminated Phase 2

• 1 other identifier: EORTC-62993
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoma

Keywords

metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor

Interventions

cisplatin DRUG

etoposide DRUG

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (1)

Institute of Cancer Research - UK

Sutton, England, SM2 5NG, United Kingdom

Location

MeSH Terms

Conditions

Sarcoma; Neuroectodermal Tumors, Primitive, Peripheral

Interventions

Cisplatin; Etoposide

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Ian R. Judson, MA, MD, FRCP

  Institute of Cancer Research, United Kingdom

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2001
• First Posted: January 27, 2003
• Study Start: January 1, 2001
• Primary Completion: December 1, 2002
• Last Updated: September 24, 2012

Record last verified: 2012-09

Locations

GB (1)