This partially randomized phase II/III trial studies how well, in combination with surgery, cisplatin and combination chemotherapy works in treating children and young adults with hepatoblastoma or hepatocellular carcinoma. Drugs used in chemotherapy, such as cisplatin, doxorubicin, fluorouracil, vincristine sulfate, carboplatin, etoposide, irinotecan, sorafenib, gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving combination chemotherapy may kill more tumor cells than one type of chemotherapy alone.
Local Recruitment Point of Contact
Jaclyn Hung
+1 (210) 450-5358
hungj@uthscsa.edu
Principal Investigator
Anne-Marie Langevin
Regulatory Point of Contact
Virginia Diaz
(210) 562-9149
diazvr@uthscsa.edu
Regulatory Point of Contact
Jaclyn Hung
+1 (210) 450-5358
hungj@uthscsa.edu
| Arm | Description | Intervention |
|---|---|---|
GROUP A2 (NON-WDF) | Patients receive cisplatin IV over 6 hours on day 1 following surgery. Treatment repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. | Given IV Other names:
Correlative studies |
GROUP B1 ARM 6-CDDP | Patients receive cisplatin IV over 6 hours on day 1. Treatment repeats every 14 days for 6 cycles (2 pre-surgery, 4 post-surgery) in the absence of disease progression or unacceptable toxicity. | Given IV Other names:
Correlative studies |
GROUP C ARM C5VD | Patients receive cisplatin IV over 6 hours on day 1, 5-fluorouracil IV over 1-15 minutes, vincristine sulfate IV over 1 minute on days 1, 8, and 15 and doxorubicin IV over 1-15 minutes on days 1 and 2. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo surgery after cycle 2 or 4. | Given IV Other names:
Correlative studies Given IV Other names:
Given IV Other names:
Given IV Other names:
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GROUP D1 | SIOPEL-4 INDUCTION: Patients receive cisplatin IV over 6 hours on days 1, 8, and 15 (for cycles 1 and 2) and days 1 and 8 (for cycle 3) and doxorubicin IV over 1-15 minutes on days 8 and 9 during cycles 1 and 2 and days 1 and 2 during cycle 3. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients with lung complete remission (either with chemotherapy and/or surgery) receive carboplatin IV over 1 hour on day 1 and doxorubicin IV over 1-15 minutes on days 1 and 2. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. | Given IV Other names:
Correlative studies Given IV Other names:
Given IV Other names:
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GROUP D2 ARM VI | SIOPEL-4 IV INDUCTION: Patients receive cisplatin IV over 6 hours on days 1, 8, and 15 (for cycles 1 and 2) and days 1 and 8 (for cycle 3) and doxorubicin IV over 1-15 minutes on days 8 and 9. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients receive carboplatin IV over 1 hour on days 1 and 2 and doxorubicin IV over 1-15 minutes on days 1 and 2 during cycles 1, 3 and 5. Patients also receive vincristine sulfate IV over 1 minute on days 1 and 8 and irinotecan IV over 90 minutes QD on days 1 to 5 of cycles 2, 4 and 6. Treatments repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. | Given IV Other names:
Correlative studies Given IV Other names:
Given IV Other names:
Given IV Other names:
Given IV |
GROUP E2 (PLADO) | Patients receive cisplatin IV over 6 hours on day 1 and doxorubicin IV over 1-15 minutes on days 1 and 2 following surgery. Treatments repeat every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. | Given IV Other names:
Correlative studies Given IV Other names:
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GROUP F ARM 2 (P/GEMOX) | Patients receive cisplatin IV over 6 hours on day 1, doxorubicin IV over 1-15 minutes on days 1 and 2 and sorafenib PO BID on days 3-14 of cycles 1 and 3. Patients also receive gemcitabine IV over 90 minutes on day 1, oxaliplatin IV over 2 hours on day 1 and sorafenib PO on days 1-14 of cycles 2 and 4. Patients may undergo surgery, if tumors are resectable, or receive an additional 4 cycles of the treatment. | Given IV Other names:
Given IV Other names:
Correlative studies Given IV Other names:
Given IV Other names:
Given PO Other names:
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Group A1 (WDF) | Patients undergo observation. | Correlative studies Undergo watchful waiting Other names:
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GROUP B1 ARM 4-CDDP | Patients receive cisplatin IV over 6 hours on day 1. Treatment repeats every 14 days for 4 cycles (2 pre-surgery, 2 post-surgery) in the absence of disease progression or unacceptable toxicity. | Given IV Other names:
Correlative studies |
GROUP B2 (UNRESECTABLE) | Patients receive cisplatin IV over 6 hours on day 1. Treatment repeats every 14 days for 6 cycles (4 pre-surgery, 2 post-surgery). | Given IV Other names:
Correlative studies |
GROUP C ARM CDDP | Patients receive cisplatin IV over 6 hours on day 1. Treatment repeats every 14 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo surgery after cycle 2 or 4. | Given IV Other names:
Correlative studies |
GROUP D2 ARM CE | SIOPEL-4 IV INDUCTION: Patients receive cisplatin IV over 6 hours on days 1, 8, and 15 (for cycles 1 and 2) and days 1 and 8 (for cycle 3) and doxorubicin IV over 1-15 minutes on days 8 and 9. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients receive carboplatin IV over 1 hour on days 1 and 2, doxorubicin IV over 1-15 minutes on days 1 and 2 during cycles 1, 3 and 5, and carboplatin over 1 hour and etoposide IV over 2 hours on day 1 and 2 of cycles 2, 4 and 6. Treatments repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. | Given IV Other names:
Given IV Other names:
Correlative studies Given IV Other names:
Given IV Other names:
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GROUP E1 | Patients undergo observation only. | Correlative studies Undergo watchful waiting Other names:
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GROUP F ARM 1 (PLADO) | Patients receive cisplatin IV over 6 hours on day 1, doxorubicin IV over 1-15 minutes on days 1 and 2 and sorafenib PO BID on days 3-21. Treatments repeat every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients may undergo surgery, if tumors are resectable, or receive an additional 3 cycles of the treatment. | Given IV Other names:
Correlative studies Given IV Other names:
Given PO Other names:
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