Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma
|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: NCT00055939|
Recruitment Status : Completed
First Posted : March 7, 2003
Last Update Posted : May 16, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Drug: exatecan mesylate||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||April 2006|
|Actual Study Completion Date :||April 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.|