NCT00055939

Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 children who have relapsed or refractory rhabdomyosarcoma.

Detailed description

OBJECTIVES: * 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.

Conditions

• Sarcoma

Interventions

Type	Name	Description
DRUG	exatecan mesylate

Timeline

• Start date: 2003-01-01
• Primary completion: 2006-04-01
• Completion: 2006-04-01
• First posted: 2003-03-07
• Last updated: 2012-05-16

Locations

9 sites across 2 countries: United States, Canada