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 ClinicalTrials.gov)
DFCI Protocol ID: 09-379
RATIONALE: 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. PURPOSE: 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.
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
Contacts:
Dana-Farber Cancer Institute:
Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP,
ctip@partners.org
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