NCT00021242

Docetaxel in Treating Children With Relapsed or Refractory Acute Lymphoblastic or Acute Myeloid Leukemia

A Phase II Study of Docetaxel (Taxotere) (NSC# 628503, IND# 59,761) in Children With Refractory Leukemias

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating children who have relapsed or refractory acute lymphoblastic or acute myeloid leukemia.

Detailed description

OBJECTIVES: * Determine the response rate in pediatric patients with relapsed or refractory acute lymphoblastic or acute myeloid leukemia treated with docetaxel. * Determine the toxicity of this regimen in these patients. OUTLINE: Patients receive docetaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 10-20 patients will be accrued for this study within 1 year.

Conditions

• Leukemia

Interventions

Type	Name	Description
DRUG	docetaxel	Continuous IV infusion

Timeline

• Start date: 2002-08-01
• Primary completion: 2006-03-01
• Completion: 2006-09-01
• First posted: 2003-01-27
• Last updated: 2014-08-08

Locations

228 sites across 7 countries: United States, Australia, Canada, Netherlands, New Zealand, Puerto Rico, Switzerland