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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00055952
Recruitment Status : Completed
First Posted : March 7, 2003
Last Update Posted : May 16, 2012
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Tracking Information
First Submitted Date  ICMJE March 6, 2003
First Posted Date  ICMJE March 7, 2003
Last Update Posted Date May 16, 2012
Study Start Date  ICMJE January 2003
Actual Primary Completion Date April 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00055952 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exatecan Mesylate in Treating Patients With Ewing's Sarcoma, Primitive Neuroectodermal Tumor, or Desmoplastic Small Round Cell Tumor
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sarcoma
Intervention  ICMJE Drug: exatecan mesylate
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE April 2006
Actual Primary Completion Date April 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00055952
Other Study ID Numbers  ICMJE CDR0000271889
DAIICHI-8951A-PRT034
SJCRH-DXEWS
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daiichi Sankyo, Inc.
Study Sponsor  ICMJE Daiichi Sankyo, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Robert L. DeJager, MD, FACP Daiichi Sankyo, Inc.
PRS Account Daiichi Sankyo, Inc.
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP