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

This study is ongoing, but not recruiting participants.
Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Exatecan Mesylate in Treating Patients With Ewing's Sarcoma, Primitive Neuroectodermal Tumor, or Desmoplastic Small Round Cell Tumor
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)
Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating patients who have relapsed or refractory Ewing's sarcoma or peripheral primitive neuroectodermal tumor or desmoplastic small round cell tumor.

Detailed Description

OBJECTIVES:

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

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.

PROJECTED ACCRUAL: 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.

Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Open Label
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Sarcoma
Intervention  Drug: exatecan mesylate
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment 
Start Date  January 2003
Completion Date
Eligibility 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

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/mm^3
  • Platelet count at least 75,000/mm^3
  • 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

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
Gender Both
Ages
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States,   Canada
Administrative Information Fields
NCT ID  NCT00055952
Organization ID CDR0000271889
Secondary IDs †† DAIICHI-8951A-PRT034, SJCRH-DXEWS
Study Sponsor  Daiichi Sankyo Inc.
Collaborators ††
Investigators 
Study Chair:     Robert L. DeJager, MD, FACP     Daiichi Sankyo Inc.    
Information Provided By National Cancer Institute (NCI)
Verification Date June 2004
First Received Date  March 6, 2003
Last Updated Date July 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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