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Alkylating agents

Combination Chemotherapy for Liver Cancer

Phase 3

Waitlist Available

Led By Gregory M Tiao

Research Sponsored by Children's Oncology Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 60 mL/min/1.73 m^2 or A serum creatinine based on age/gender as specified

Patients must be newly diagnosed with histologically-proven primary pediatric hepatic malignancies including hepatoblastoma or hepatocellular carcinoma, except as noted below; patients with a diagnosis of hepatocellular neoplasm, not otherwise specified, should be classified and treated per hepatoblastoma treatment arms; note that rapid central pathology review is required in some cases; all patients with histology consistent with pure small cell undifferentiated (SCU) HB will be required to have testing for INI1/SMARCB1 by immunohistochemistry (IHC) according to the practices at the institution

Must not have

Patients who previously received a solid organ transplant, other than those who previously received an orthotopic liver transplantation (OLT) as primary treatment of their hepatocellular carcinoma

Prior chemotherapy or tumor directed therapy (i.e. radiation therapy, biologic agents, local therapy (embolization, radiofrequency ablation, and laser); therefore, patients with a pre-disposition syndrome who have a prior malignancy are not eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is studying a combination of cisplatin and other drugs as a possible treatment for hepatoblastoma or hepatocellular carcinoma.

Who is the study for?

This trial is for children and young adults with hepatoblastoma or liver cancer who have undergone surgery. They must be newly diagnosed, have proper organ function, not received prior cancer treatments except certain surgeries, and agree to contraception if of childbearing potential. Those with uncontrolled infections or on other cancer drugs can't join.

What is being tested?

The study tests how well cisplatin combined with other chemotherapy drugs works after surgery in treating liver cancers in the young. It's a phase II/III trial where these drugs are given to see if they're better at killing tumor cells than one drug alone.

What are the potential side effects?

Chemotherapy may cause nausea, vomiting, hair loss, fatigue, increased risk of infection due to low blood cell counts, mouth sores, and possible damage to organs like the heart and kidneys. Each drug has its own set of potential side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function is normal or near normal.

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I am newly diagnosed with a specific type of liver cancer as a child.

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My body surface area is at least 0.6 square meters.

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I can take care of myself, but might not be able to do heavy physical work.

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My bilirubin levels are within 5 times the normal range for my age.

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My cancer's tissue test for INI1/SMARCB1 is positive.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a liver transplant for liver cancer but no other organ transplants.

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I have not had chemotherapy, radiation, or other tumor treatments before.

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I have nerve damage affecting my limbs or a history of long QT syndrome in my family.

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I have a known DPD deficiency.

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I have chronic bowel issues or I'm taking St. John's wort and can't stop before the trial.

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I do not have any infections that are currently uncontrolled.

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I am not pregnant and can take a pregnancy test if needed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Event-free survival (EFS)

Percentage of Group B2 participants with resectable tumors

Response rate for Group F patients

Other study objectives

Best response

Failure free survival

Overall survival

+5 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

15Treatment groups

Experimental Treatment

Active Control

Group I: GROUP F ARM 2 (P/GEMOX)Experimental Treatment7 Interventions

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. Patients may optionally undergo blood sample collection on study.

Group II: GROUP F ARM 1 (PLADO)Experimental Treatment4 Interventions

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. Patients may optionally undergo blood sample collection on study.

Group III: GROUP E2 (PLADO)Experimental Treatment3 Interventions

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. Patients may optionally undergo blood sample collection on study.

Group IV: GROUP D2 ARM VIExperimental Treatment6 Interventions

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. Patients may optionally undergo blood sample collection on study.

Group V: GROUP D2 ARM CEExperimental Treatment5 Interventions

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. Patients may optionally undergo blood sample collection on study.

Group VI: GROUP D1Experimental Treatment4 Interventions

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. Patients may optionally undergo blood sample collection on study.

Group VII: GROUP C ARM CDDPExperimental Treatment3 Interventions

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. Patients may optionally undergo blood sample collection on study.

Group VIII: GROUP C ARM C5VDExperimental Treatment5 Interventions

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. Patients may optionally undergo blood sample collection on study.

Group IX: GROUP B2 ARM IIExperimental Treatment2 Interventions

Patients receive cisplatin IV over 6 hours on day 1. Treatment repeats every 14 days for up to 6 total cycles. Patients may optionally undergo blood sample collection on study.

Group X: GROUP B2 ARM IExperimental Treatment3 Interventions

Patients receive cisplatin IV over 6 hours on day 1. Treatment repeats every 14 days for up to 6 total cycles (4 pre-surgery, 2 post-surgery). After cycle 4, patients undergo surgery, then continue with 2 additional cycles of cisplatin. Patients may optionally undergo blood sample collection on study.

Group XI: GROUP B1 ARM 6-CDDPExperimental Treatment3 Interventions

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. Patients may optionally undergo blood sample collection on study.

Group XII: GROUP B1 ARM 4-CDDPExperimental Treatment2 Interventions

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. Patients may optionally undergo blood sample collection on study.

Group XIII: GROUP A2 (NON-WDF)Experimental Treatment2 Interventions

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. Patients may optionally undergo blood sample collection on study.

Group XIV: Group A1 (WDF)Active Control2 Interventions

Patients undergo observation. Patients may optionally undergo blood sample collection on study.

Group XV: GROUP E1Active Control3 Interventions

Patients undergo observation only. Patients may optionally undergo blood sample collection on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2030