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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


Phase 2
15 Years
65 Years
Not Enrolling
Both
Sarcoma

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Ian R. Judson, MA, MD, FRCP

Investigator Role:

Study Chair

Investigator Affiliation:

Institute of Cancer Research, United Kingdom

Authority:

United States: Federal Government

Study ID:

EORTC-62993

NCT ID:

NCT00014313

Start Date:

January 2001

Completion Date:

Related Keywords:

  • Sarcoma
  • metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • Neuroectodermal Tumors
  • Neuroectodermal Tumors, Primitive
  • Sarcoma, Ewing's
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma

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