Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Exatecan Mesylate in Treating Patients With Ewing's Sarcoma, Primitive Neuroectodermal Tumor, or Desmoplastic Small Round Cell Tumor

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	Any age	Pharmaceutical / Industry	DAIICHI-8951A-PRT034 SJCRH-DXEWS, NCT00055952

Objectives

1. Determine the objective response rate in patients with Ewing's sarcoma, primitive neuroectodermal tumor, or desmoplastic small round cell tumor treated with exatecan mesylate.
2. Determine the time to tumor progression in patients treated with this drug.
3. Determine median survival and 6- and 12-month survival of patients treated with this drug.
4. Determine the pain response in patients treated with this drug.
5. Determine the qualitative and quantitative toxic effects of this drug in these patients.
6. Determine the pharmacokinetics of this drug in these patients.

Entry Criteria

Disease Characteristics:

• One of the following histologically confirmed diagnoses:
  • Relapsed or refractory Ewing's sarcoma or primitive neuroectodermal tumor
  • Desmoplastic small round cell tumor



• Measurable disease
  • The following are not considered measurable disease:
    • Ascites
    • Pleural effusion
    • Lytic bone lesions



• No symptomatic brain metastases

Prior/Concurrent Therapy:

Biologic therapy

• At least 3 months since prior autologous bone marrow or stem cell transplantation
• No concurrent biologic therapy

Chemotherapy

• Recovered from prior systemic chemotherapy
• Prior topoisomerase I inhibitor therapy allowed
• No other concurrent chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• More than 4 weeks since prior cranial, spinal, or whole pelvis radiotherapy
• More than 4 weeks since prior radiotherapy to 25% of bone marrow reserve
• No concurrent radiotherapy

Surgery

• At least 4 weeks since prior major surgery and recovered
• No concurrent surgery

Other

• More than 28 days since prior investigational drugs (including analgesics or antiemetics)
• No more than 2 prior treatment regimens for this disease
• No other investigational drugs during and for 28 days after study therapy
• No other concurrent anticancer therapy
• No concurrent grapefruit or grapefruit juice

Patient Characteristics:

Age

• Any age

Performance status

• ECOG 0-2 (over 10 years of age)
• Lansky 60-100% (10 years of age and under)

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute neutrophil count at least 750/mm³
• Platelet count at least 75,000/mm³
• Hemoglobin at least 8.5 g/dL

Hepatic

• Bilirubin no greater than 2.0 mg/dL
• AST or ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
• Albumin at least 2.8 g/dL

Renal

• Creatinine less than 1.5 times ULN

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No active serious infection
• No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
• No overt psychosis or mental disability that would preclude informed consent
• No other life-threatening illness within the past 6 months

Expected Enrollment

A total of 13-27 patients will be accrued for stratum I within 12 months. A total of 9-17 patients will be accrued for stratum II within 15 months.

Outline

This is an open-label, non-randomized, multicenter study. Patients are stratified according to disease (relapsed or refractory localized or metastatic Ewing's sarcoma or primitive neuroectodermal tumor vs desmoplastic small round cell tumor).

Patients receive exatecan mesylate IV over 30 minutes on days 1-5. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity for a maximum of 12 courses, or 6 courses beyond maximal response (whichever is longer).

Patients are followed every 3 months for 1 year after withdrawal from study.

Trial Contact Information

Trial Lead Organizations

Daiichi Sankyo, Incorporated

Robert L. DeJager, MD, FACP, Protocol chair		Ph: 201-573-7160 Email: RDeJager@DaiichiUS.com

Registry Information
Official Title		A Phase II Study Of Intravenous DX-8951f (EXATECAN MESYLATE) Administered Daily For Five Days Every Three Weeks To Pediatric And Young Adult Patients With Ewing's Sarcoma (ES), Primitive Neuroectodermal Tumor (PNET), Or Desmoplastic Small Round Cell Tumor (DSRCT)
Trial Start Date		2003-01-07
Registered in ClinicalTrials.gov		NCT00055952
Date Submitted to PDQ		2003-01-23
Information Last Verified		2004-06-03
NCI Grant/Contract Number		P30-CA21765

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