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Sponsored by: |
European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00014313 |
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 II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
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 Start Date: | January 2001 |
OBJECTIVES:
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.
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:
Evidence of a chromosomal translocation involving the EWS gene by conventional cytogenetics
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United Kingdom, England | |
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 |
Study ID Numbers: | CDR0000068531, EORTC-62993 |
Study First Received: | April 10, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00014313 |
Health Authority: | United States: Federal Government |
metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor |
Neuroectodermal Tumors, Primitive Malignant mesenchymal tumor Ewing's family of tumors Osteosarcoma Etoposide phosphate Osteogenic sarcoma Soft tissue sarcomas Neuroectodermal Tumors Neoplasms, Connective and Soft Tissue Ewing's sarcoma |
Sarcoma, Ewing's Cisplatin Peripheral neuroectodermal tumor Neoplasms, Germ Cell and Embryonal Sarcoma Neuroepithelioma Etoposide Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms, Bone Tissue Neoplasms by Histologic Type Radiation-Sensitizing Agents Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Neoplasms, Nerve Tissue Neoplasms, Connective Tissue Neoplasms, Neuroepithelial Antineoplastic Agents, Phytogenic Pharmacologic Actions |