NCT00287976

Irinotecan in Treating Young Patients With Refractory or Recurrent Hepatoblastoma

Irinotecan Single-Drug Treatment For Children With Refractory or Recurrent Hepatoblastoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Children's Cancer and Leukaemia Group · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well irinotecan works in treating young patients with refractory or recurrent hepatoblastoma.

Detailed description

OBJECTIVES: Primary * Determine the biological activity of irinotecan hydrochloride, when given on a prolonged schedule, in terms of response rate and rate of early progression, in young patients with refractory or recurrent hepatoblastoma. Secondary * Determine the duration of response in patients showing stable disease or an objective response (partial or complete response) to this drug. * Determine the time to progression and overall survival of patients treated with this drug. * Determine the rate of resectability in patients treated with this drug. * Determine the toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive irinotecan IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients undergo evaluation for tumor resectability after courses 2, 3, or 4. Patients whose disease is considered resectable at any of these time points proceed to surgery. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Conditions

• Liver Cancer

Interventions

Type	Name	Description
DRUG	irinotecan hydrochloride

Timeline

• Start date: 2003-04-01
• Primary completion: 2008-12-01
• First posted: 2006-02-07
• Last updated: 2013-09-17

Locations

22 sites across 3 countries: Ireland, Netherlands, United Kingdom