Chemotherapy in Treating Patients With Metastatic Ewing's Sarcoma or Primitive Neuroectodermal Tumor
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Sarcoma |
Drug: cisplatin Drug: etoposide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: 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 |
| Enrollment: | 3 |
| Study Start Date: | January 2001 |
| Primary Completion Date: | December 2002 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 15 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United Kingdom | |
| Institute of Cancer Research - UK | |
| Sutton, England, United Kingdom, SM2 5NG | |
| Study Chair: | Ian R. Judson, MA, MD, FRCP | Institute of Cancer Research, United Kingdom |
More Information
Additional Information:
No publications provided
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00014313 History of Changes |
| Other Study ID Numbers: | EORTC-62993, EORTC-62993 |
| Study First Received: | April 10, 2001 |
| Last Updated: | September 20, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
|
metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor |
Additional relevant MeSH terms:
|
Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Sarcoma, Ewing's Neuroectodermal Tumors, Primitive, Peripheral Sarcoma Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Glandular and Epithelial Osteosarcoma |
Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Etoposide phosphate Cisplatin Etoposide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 19, 2013