Irinotecan in Treating Young Patients With Refractory or Recurrent Hepatoblastoma

Children's Cancer and Leukaemia Group

Status and phase: Unknown; Phase 2

Conditions: Liver Cancer

Treatments: Drug: irinotecan hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT00287976

CCLG-LT-2003-01

EU-20589

CDR0000454758

CCLG-IRINOTECAN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: Under 20 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Diagnosis of hepatoblastoma

  • Refractory or recurrent disease

    • Failed prior first-line or second-line treatment

  • Metastatic disease allowed

• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

  • Elevated serum alpha-fetoprotein (AFP) allowed

• No hepatocellular carcinoma

PATIENT CHARACTERISTICS:

• Lansky performance status 50-100% in patients ≤ 10 years of age OR Karnofsky performance status 50-100% in patients > 10 years of age
• Life expectancy > 8 weeks
• Hemoglobin > 8 g/dL
• Absolute neutrophil count > 1,000/mm^3
• Platelet count > 100,000/mm^3
• Serum bilirubin ≤ 2 times normal
• AST/ALT ≤ 2 times normal
• Serum creatinine ≤ 3 times normal
• Normal metabolic parameters (i.e., serum electrolytes, glucose, calcium, and phosphate)
• Not pregnant or nursing
• No severe uncontrolled infection or enterocolitis

PRIOR CONCURRENT THERAPY:

• Recovered from toxicity of prior therapy
• No chemotherapy within 3 weeks prior to study entry
• No prior irinotecan
• No other concurrent anticancer therapy