Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Liver Cancer

Status: Recruiting
Phase: Phase 3
Diagnosis: Pediatric Solid Tumors
NCT ID: NCT00980460 (View complete trial on
DFCI Protocol ID: 09-379


This phase III trial is studying the side effects of giving doxorubicin hydrochloride together with combination chemotherapy and to compare different chemotherapy regimens to see how well they work in treating young patients with newly diagnosed liver cancer. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether surgery is more effective with or without chemotherapy or which chemotherapy regimen may be more effective in treating young patients with liver cancer.


Conducting Institutions:
Dana-Farber Cancer Institute, Massachusetts General Hospital, Children's Hospital Boston

Overall PI:
Mary Huang, MD, Massachusetts General Hospital

Site-responsible Investigators:
Allison O'Neill, MD, Children's Hospital Boston

Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP,
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

DISEASE CHARACTERISTICS: - Histologically confirmed newly diagnosed hepatoblastoma - All stages* and all histologic variants allowed NOTE: *Patients with Stage I or II disease must have specimens submitted for rapid central pathology review by Day 14 after initial surgical resection - Patients are assigned to the following risk groups: - Very low-risk: grossly resected tumors (stage I) with PFH AND an elevated AFP level > 100 ng/mL - Low-risk: grossly resected tumors (stage I-II) AND lacking any unfavorable biologic feature (i.e., any SCU elements or a low diagnostic AFP level < 100 ng/mL) - Intermediate-risk: gross residual disease/unresectable disease OR grossly resected disease with any SCU elements but no metastatic disease and no low diagnostic AFP level < 100 ng/mL - High-risk: metastatic disease OR low diagnostic AFP level < 100 ng/mL regardless of stage PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - ANC* > 750/μL - Platelet count* > 75,000/μL - Creatinine clearance* or radioisotope glomerular filtration rate* ≥ 70 mL/min OR serum creatinine* based on age/gender as follows: - 1 month to < 6 months: 0.4 mg/dL - 6 months to < 1 year: 0.5 mg/dL - 1 to < 2 years: 0.6 mg/dL - 2 to < 6 years: 0.8 mg/dL - 6 to < 10 years: 1 mg/dL - 10 to < 13 years: 1.2 mg/dL - 13 to < 16 years: 1.5 mg/dL (male) or 1.4 mg/dL (female) - ≥ 16 years: 1.7 mg/dL (male) 1.4 mg/dL (female) - Total bilirubin* < 1.5 times upper limit of normal (ULN) for age - SGOT (AST)* or SGPT (ALT)* < 10 times ULN for age - Shortening fraction** ≥ 27% by echocardiogram - Ejection fraction** ≥ 47% by radionuclide angiogram (MUGA) - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception NOTE: *Organ function requirements are not required for enrolled patients who are stage I, PFH and will not be receiving chemotherapy NOTE: **For intermediate- and high-risk patients who will be assigned to protocol chemotherapy PRIOR CONCURRENT THERAPY: - Prior surgical resection of some or all sites of hepatoblastoma allowed - No prior chemotherapy for hepatoblastoma or other hepatoblastoma-directed therapy (e.g., radiation therapy, biologic agents, local therapy [embolization, radiofrequency ablation, laser]) - No other prior chemotherapy - No concurrent radiotherapy
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