Irinotecan in Treating Young Patients With Refractory or Recurrent Hepatoblastoma

Phase 2

• Conditions: Liver Cancer

• Registration Number: NCT00287976
• Lead Sponsor: Children's Cancer and Leukaemia Group

Brief 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.

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2006-02-06
• Study First Submitted QC: 2006-02-06
• Study First Posted: 2006-02-07
• Primary Completion: 2008-12
• Status Verified: 2009-06
• Last Update Submitted: 2013-09-16
• Last Update Posted: 2013-09-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Best overall response (complete response and partial response)

Secondary Outcome Measures

Name	Time	Method
Early progression
Death
Disease progression or recurrence
Surgical resection (complete or incomplete)

Trial Locations

Locations (21)

Our Lady's Hospital for Sick Children Crumlin; 🇮🇪 Dublin, Ireland

Emma Kinderziekenhuis; 🇳🇱 Amsterdam, Netherlands

Birmingham Children's Hospital; 🇬🇧 Birmingham, England, United Kingdom

Institute of Child Health at University of Bristol; 🇬🇧 Bristol, England, United Kingdom

Addenbrooke's Hospital; 🇬🇧 Cambridge, England, United Kingdom

Leeds Cancer Centre at St. James's University Hospital; 🇬🇧 Leeds, England, United Kingdom

Leicester Royal Infirmary; 🇬🇧 Leicester, England, United Kingdom

Royal Liverpool Children's Hospital, Alder Hey; 🇬🇧 Liverpool, England, United Kingdom

Royal London Hospital; 🇬🇧 London, England, United Kingdom

Great Ormond Street Hospital for Children; 🇬🇧 London, England, United Kingdom

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