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)
- Determine the objective response rate in patients with Ewing's sarcoma, primitive
neuroectodermal tumor, or desmoplastic small round cell tumor treated with exatecan
- 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
- Determine the pain response in patients treated with this drug.
- Determine the qualitative and quantitative toxic effects of this drug in these
- 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.
Masking: Open Label, Primary Purpose: Treatment
Robert L. DeJager, MD, FACP
Daiichi Sankyo Inc.
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|Medical City Dallas Hospital||Dallas, Texas 75230|
|University of Colorado Cancer Center at University of Colorado Health Sciences Center||Denver, Colorado 80010|
|Cancer Institute of New Jersey||New Brunswick, New Jersey 08901|
|Nemours Children's Clinic||Jacksonville, Florida 32207|
|St. Jude Children's Research Hospital||Memphis, Tennessee 38105-2794|
|Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas||Dallas, Texas 75390-9063|