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Alkylating agents

Combination Chemotherapy for Liver Cancer

Phase 2 & 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Event-free survival (EFS)

Percentage of Group B2 participants with resectable tumors

Response rate for Group F patients

Other outcome measures

Best response

Failure free survival

Overall survival

+5 more

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Group XIV: Group A1 (WDF)Active Control2 Interventions

Patients undergo observation.

Group XV: GROUP E1Active Control3 Interventions

Patients undergo observation only.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oxaliplatin

2011

Completed Phase 4

~2560

Vincristine Sulfate

2005

Completed Phase 3

~10110

Fluorouracil

2014

Completed Phase 3

~11540

Doxorubicin

2012

Completed Phase 3

~7940

Resection

2021

Completed Phase 2

~410

Gemcitabine

2017

Completed Phase 3

~2070

Sorafenib

2014

Completed Phase 3

~1670

Etoposide

2010

Completed Phase 3

~2440

Carboplatin

2014

Completed Phase 3

~6670

Cisplatin

2013

Completed Phase 3

~1940

Irinotecan

2017

Completed Phase 4

~2680

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor

453 Previous Clinical Trials

237,163 Total Patients Enrolled

10 Trials studying Hepatoblastoma

988 Patients Enrolled for Hepatoblastoma

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,932,616 Total Patients Enrolled

23 Trials studying Hepatoblastoma

4,134 Patients Enrolled for Hepatoblastoma

Gregory M TiaoPrincipal InvestigatorChildren's Oncology Group

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03533582 — Phase 2 & 3

Hepatoblastoma Research Study Groups: GROUP C ARM C5VD, GROUP F ARM 2 (P/GEMOX), GROUP D1, GROUP F ARM 1 (PLADO), GROUP C ARM CDDP, GROUP D2 ARM CE, Group A1 (WDF), GROUP A2 (NON-WDF), GROUP B1 ARM 4-CDDP, GROUP B1 ARM 6-CDDP, GROUP B2 ARM I, GROUP B2 ARM II, GROUP D2 ARM VI, GROUP E1, GROUP E2 (PLADO)

Hepatoblastoma Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT03533582 — Phase 2 & 3

Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03533582 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are doctors treating most often with GROUP B2 (UNRESECTABLE)?

"GROUP B2 (UNRESECTABLE) is a medication used to treat merkel cell cancer. However, it has also shown efficacy when treating neoplasm metastasis, initial treatment, and prostate cancer."

Answered by AI

Are people with the required medical conditions currently being recruited for this clinical trial?

"That is correct, the information available on clinicaltrials.gov supports that this study is actively looking for patients. The 537 patients needed for the study are being recruited from 100 different sites. The study was first posted on May 23rd, 2018 and updated as recently as October 19th, 2020."

Answered by AI

From how many different sites is this research being conducted?

"This study is looking for 100 patients from various locations, such as Newark Beth Israel Medical Center, Mary Bridge Children's Hospital and Health Center, Madigan Army Medical Center, and other locations."

Answered by AI

Are there other ongoing or completed research projects studying GROUP B2 (UNRESECTABLE)?

"At the moment, there are 2464 separate clinical trials underway studying GROUP B2 (UNRESECTABLE) cancer. 740 of those trials are currently in Phase 3. Most of the trials for GROUP B2 (UNRESECTABLE) cancer are based in Guangzhou, Guangdong, but there are 117788 locations running trials for this treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cisplatin and Combination Chemotherapy in Treating Children and Young Adults With Hepatoblastoma or Liver Cancer After Surgery

2018. "Cisplatin and Combination Chemotherapy in Treating Children and Young Adults With Hepatoblastoma or Liver Cancer After Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03533582.

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