Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma
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 children who have relapsed or refractory rhabdomyosarcoma.
|Study Design:||Allocation: Non-Randomized
Masking: None (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 Patients With Relapsed Or Refractory Rhabdomyosarcoma|
|Study Start Date:||January 2003|
|Study Completion Date:||April 2006|
|Primary Completion Date:||April 2006 (Final data collection date for primary outcome measure)|
- Determine the objective response rate (complete and partial responses) in pediatric patients with relapsed or refractory rhabdomyosarcoma treated with exatecan mesylate.
- Determine the time to tumor progression in patients treated with this drug.
- Determine the median survival and survival at 6 and 12 months in patients treated with this drug.
- Assess pain in patients treated with this drug.
- Evaluate the quantitative and qualitative toxic effects of this drug in these patients.
- Evaluate the pharmacokinetics of this drug in these patients.
OUTLINE: This is an open-label, nonrandomized, multicenter study.
Patients receive exatecan mesylate IV over 30 minutes on days 1-5. Treatment repeats every 3 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 6 additional courses beyond CR.
PROJECTED ACCRUAL: A total of 13-27 patients will be accrued for this study within 1 year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00055939
|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|
|Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Study Chair:||Robert L. DeJager, MD, FACP||Daiichi Sankyo, Inc.|