NCT00003994

Brief Summary

Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy. It is not yet known which chemotherapy regimen is most effective for children and young adults with liver cancer. This randomized phase III trial is studying giving combination chemotherapy together with amifostine to see how well it works compared to combination chemotherapy alone in treating patients with liver cancer.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
277

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1999

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Last Updated

June 14, 2013

Status Verified

June 1, 2013

Enrollment Period

8.6 years

First QC Date

November 1, 1999

Last Update Submit

June 13, 2013

Conditions

Childhood HepatoblastomaRecurrent Childhood Liver CancerStage I Childhood Liver Cancer

Outcome Measures

Primary Outcomes (2)

  • Event-free survival (EFS) rates

    EFS rates will be estimated using the method of Kaplan and Meier. Survival curves will be compared using stratified logrank tests.

    Up to 8 years

  • Toxicity rates assessed using National Cancer Institute (NCI) Common Toxicity Criteria (CTC)

    For comparing the toxicity rates in the +/- amifostine arms, stratified binomial test for proportions (Mantel-Haenszel) will be used assuming no qualitative interaction between the two chemotherapy regimens and amifostine trihydrate.

    Up to 8 years

Study Arms (4)

Arm I (cisplatin, vincristine sulfate, fluorouracil)

EXPERIMENTAL

Patients receive therapeutic conventional surgery (tumor resection). Patients receive cisplatin IV over 4 hours on day 1, vincristine sulfate IV on days 3, 10, and 17, and fluorouracil on day 3.

Procedure: therapeutic conventional surgeryDrug: cisplatinDrug: vincristine sulfateDrug: fluorouracil

Arm II (cisplatin, vincristine, fluorouracil, amifostine)

EXPERIMENTAL

Patients receive therapeutic conventional surgery (tumor resection). Patients receive treatment as in arm I with the addition of amifostine trihydrate IV over 15 minutes prior to cisplatin on day 1.

Procedure: therapeutic conventional surgeryDrug: cisplatinDrug: vincristine sulfateDrug: fluorouracilDrug: amifostine trihydrate

Arm III (carboplatin, cisplatin)

EXPERIMENTAL

Patients receive therapeutic conventional surgery (tumor resection). Patients receive carboplatin IV over 1 hour on day 1 and cisplatin IV over 4 hours on day 15.

Procedure: therapeutic conventional surgeryDrug: cisplatinDrug: carboplatin

Arm IV (carboplain, cisplatin, amifostine)

EXPERIMENTAL

Patients receive therapeutic conventional surgery (tumor resection). Patients receive treatment as in arm III with the addition of amifostine trihydrate IV over 15 minutes prior to carboplatin on day 1.

Procedure: therapeutic conventional surgeryDrug: cisplatinDrug: amifostine trihydrateDrug: carboplatin

Interventions

therapeutic conventional surgeryPROCEDURE

Undergo surgical resection

Arm I (cisplatin, vincristine sulfate, fluorouracil)Arm II (cisplatin, vincristine, fluorouracil, amifostine)Arm III (carboplatin, cisplatin)Arm IV (carboplain, cisplatin, amifostine)
cisplatinDRUG

Given IV

Also known as: CACP, CDDP, CPDD, DDP
Arm I (cisplatin, vincristine sulfate, fluorouracil)Arm II (cisplatin, vincristine, fluorouracil, amifostine)Arm III (carboplatin, cisplatin)Arm IV (carboplain, cisplatin, amifostine)
vincristine sulfateDRUG

Given IV

Also known as: leurocristine sulfate, VCR, Vincasar PFS
Arm I (cisplatin, vincristine sulfate, fluorouracil)Arm II (cisplatin, vincristine, fluorouracil, amifostine)
fluorouracilDRUG

Given IV

Also known as: 5-fluorouracil, 5-Fluracil, 5-FU
Arm I (cisplatin, vincristine sulfate, fluorouracil)Arm II (cisplatin, vincristine, fluorouracil, amifostine)
amifostine trihydrateDRUG

Given IV

Also known as: ethiofos, Ethyol, gammaphos, WR-2721
Arm II (cisplatin, vincristine, fluorouracil, amifostine)Arm IV (carboplain, cisplatin, amifostine)
carboplatinDRUG

Given IV

Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin
Arm III (carboplatin, cisplatin)Arm IV (carboplain, cisplatin, amifostine)

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Histologically proven hepatoblastoma
  • Any stage allowed(stages II-IV closed to accrual as of 11-25-03)
  • Stratum 1 (stage I):
  • Pure fetal histology
  • Complete surgical resection of tumor
  • Stratum 2 (stages I or II) (stage II closed to accrual as of 11-25-03), meeting 1 of the following criteria:
  • Complete resection of tumor with histology other than pure fetal
  • Gross resection of tumor, including resected tumors with preoperative/intraoperative rupture
  • Stratum 3 (stages III or IV) (stages III and IV closed to accrual as of 11-25-03), meeting 1 of the following criteria:
  • Unresectable tumors
  • Partial resection of tumor with measurable residual disease OR lymph node involvement
  • Measurable metastatic disease to lungs or other organs
  • No hepatocellular carcinoma
  • Creatinine normal for age
  • Glomerular filtration rate normal for age
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Oncology Group

Arcadia, California, 91006-3776, United States

Location

MeSH Terms

Conditions

Hepatoblastoma

Interventions

CisplatinVincristineFluorouracilAmifostineCarboplatin

Condition Hierarchy (Ancestors)

Neoplasms, Complex and MixedNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingOrganothiophosphatesOrganophosphatesOrganophosphorus CompoundsOrganic ChemicalsOrganothiophosphorus CompoundsSulfur CompoundsCoordination Complexes

Study Officials

  • Howard Katzenstein

    Children's Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

March 1, 1999

Primary Completion

October 1, 2007

Last Updated

June 14, 2013

Record last verified: 2013-06

Locations

US(1)