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Combination Chemotherapy With or Without Amifostine in Treating Young Patients With Liver Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00003994
First received: November 1, 1999
Last updated: June 13, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Childhood Hepatoblastoma
Recurrent Childhood Liver Cancer
Stage I Childhood Liver Cancer
Procedure: therapeutic conventional surgery
Drug: cisplatin
Drug: vincristine sulfate
Drug: fluorouracil
Drug: amifostine trihydrate
Drug: carboplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intergroup Protocol for Treatment of Children With Hepatoblastoma

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Event-free survival (EFS) rates [ Time Frame: Up to 8 years ] [ Designated as safety issue: No ]
    EFS rates will be estimated using the method of Kaplan and Meier. Survival curves will be compared using stratified logrank tests.

  • Toxicity rates assessed using National Cancer Institute (NCI) Common Toxicity Criteria (CTC) [ Time Frame: Up to 8 years ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 277
Study Start Date: March 1999
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (cisplatin, vincristine sulfate, fluorouracil)
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 surgery
Undergo surgical resection
Drug: cisplatin
Given IV
Other Names:
  • CACP
  • CDDP
  • CPDD
  • DDP
Drug: vincristine sulfate
Given IV
Other Names:
  • leurocristine sulfate
  • VCR
  • Vincasar PFS
Drug: fluorouracil
Given IV
Other Names:
  • 5-fluorouracil
  • 5-Fluracil
  • 5-FU
Experimental: Arm II (cisplatin, vincristine, fluorouracil, amifostine)
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 surgery
Undergo surgical resection
Drug: cisplatin
Given IV
Other Names:
  • CACP
  • CDDP
  • CPDD
  • DDP
Drug: vincristine sulfate
Given IV
Other Names:
  • leurocristine sulfate
  • VCR
  • Vincasar PFS
Drug: fluorouracil
Given IV
Other Names:
  • 5-fluorouracil
  • 5-Fluracil
  • 5-FU
Drug: amifostine trihydrate
Given IV
Other Names:
  • ethiofos
  • Ethyol
  • gammaphos
  • WR-2721
Experimental: Arm III (carboplatin, cisplatin)
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 surgery
Undergo surgical resection
Drug: cisplatin
Given IV
Other Names:
  • CACP
  • CDDP
  • CPDD
  • DDP
Drug: carboplatin
Given IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Experimental: Arm IV (carboplain, cisplatin, amifostine)
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 surgery
Undergo surgical resection
Drug: cisplatin
Given IV
Other Names:
  • CACP
  • CDDP
  • CPDD
  • DDP
Drug: amifostine trihydrate
Given IV
Other Names:
  • ethiofos
  • Ethyol
  • gammaphos
  • WR-2721
Drug: carboplatin
Given IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No prior biologic therapy
  • No prior chemotherapy
  • No prior endocrine therapy
  • No prior radiotherapy
  • See Disease Characteristics
  • No prior therapy except tumor resection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003994

Locations
United States, California
Children's Oncology Group
Arcadia, California, United States, 91006-3776
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Howard Katzenstein Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00003994     History of Changes
Other Study ID Numbers: P9645, NCI-2012-02306, COG-P9645, CCG-P9645, POG-9645, CDR0000067200, U10CA098543
Study First Received: November 1, 1999
Last Updated: June 13, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatoblastoma
Liver Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Complex and Mixed
Amifostine
Carboplatin
Cisplatin
Fluorouracil
Vincristine
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Radiation-Protective Agents
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 25, 2014