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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00055952
First received: March 6, 2003
Last updated: May 15, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Sarcoma
Drug: exatecan mesylate
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Study Start Date: January 2003
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00055952

Locations
United States, Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, United States, 80218
United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
United States, New Jersey
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
United States, Texas
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390-9063
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Canada, Ontario
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
Daiichi Sankyo Inc.
Investigators
Study Chair: Robert L. DeJager, MD, FACP Daiichi Sankyo Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT00055952     History of Changes
Other Study ID Numbers: CDR0000271889, DAIICHI-8951A-PRT034, SJCRH-DXEWS
Study First Received: March 6, 2003
Last Updated: May 15, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:
childhood desmoplastic small round cell tumor
metastatic childhood soft tissue sarcoma
nonmetastatic childhood soft tissue sarcoma
recurrent childhood soft tissue sarcoma
localized Ewing sarcoma/peripheral primitive neuroectodermal tumor
metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor

Additional relevant MeSH terms:
Desmoplastic Small Round Cell Tumor
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Sarcoma
Sarcoma, Ewing
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Osteosarcoma
Camptothecin
Exatecan
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 27, 2014