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Combination Chemotherapy With or Without Amifostine in Treating Young Patients With Liver Cancer
This study has been completed.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Children's Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003994
  Purpose

RATIONALE: 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.

PURPOSE: 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
Liver Cancer
 Drug: cisplatin
Drug: fluorouracil
Drug: vincristine sulfate
Procedure: adjuvant therapy
Procedure: conventional surgery
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: Intergroup Protocol for Treatment of Children With Hepatoblastoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer
Drug Information available for: Fluorouracil Vincristine Cisplatin Vincristine sulfate
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Event-free survival [ Designated as safety issue: No ]
  • Efficacy [ Designated as safety issue: No ]

Estimated Enrollment: 356
Study Start Date: March 1993
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the event-free survival rate in children with stage III or IV unresectable or metastatic hepatoblastoma treated with cisplatin, vincristine, and fluorouracil (stages III and IV closed to accrual as of 11-25-03).
  • Evaluate the efficacy of amifostine* in reducing toxicity associated with platinum agents in patients with hepatoblastoma.
  • Determine whether amifostine* effects event-free survival in these patients in response to these regimens.
  • Evaluate the event-free survival in patients with stage I pure fetal histology treated with surgery alone.
  • Evaluate the efficacy of amifostine* in reducing toxicity associated with cisplatin in patients with resected tumors.
  • Determine the response in patients treated with amifostine* in combination with these regimens.

NOTE: * Arm II (amifostine) closed to accrual as of 11-25-03; arm IV (amifostine) closed to accrual as of 4-5-02

OUTLINE: This is a randomized study. Patients are stratified according to disease stage (stage I pure fetal histology vs stage I other histology or stage II [stage II closed to accrual as of 11-25-03] vs stage III or IV [stages III and IV closed to accrual as of 11-25-03]). Patients are randomized to one of four treatment arms. (Arms III and IV closed to accrual as of 4-5-02) (Arm II closed to accrual as of 11-25-03)

All patients undergo surgical resection or attempted resection of tumor. Patients with pure fetal histology achieving complete tumor resection receive no further treatment. All other patients receive postoperative chemotherapy.

  • Arm I: Patients receive cisplatin IV over 4 hours on day 1, vincristine IV on days 3, 10, and 17, and fluorouracil on day 3.
  • Arm II (closed to accrual as of 11-25-03): Patients receive treatment as in arm I with the addition of amifostine IV over 15 minutes prior to cisplatin on day 1.
  • Arm III (closed to accrual as of 4-5-02): Patients receive carboplatin IV over 1 hour on day 1 and cisplatin IV over 4 hours on day 15.
  • Arm IV (closed to accrual as of 4-5-02): Patients receive treatment as in arm III with the addition of amifostine IV over 15 minutes prior to carboplatin on day 1. Treatment repeats every 3 weeks for 4 courses in arms I and II (arm II closed to accrual as of 11-25-03) and every 4 weeks for 4 courses in arms III and IV (arms III and IV closed to accrual as of 4-5-02) in the absence of disease progression or unacceptable toxicity. Patients with stage III or IV disease (stages III and IV closed to accrual as of 11-25-03) undergo second look surgery and receive 2 additional courses of chemotherapy if achieving complete response after surgery.

Patients are followed monthly for 6 months, every 2 months for 2 years, every 3 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 356 patients will be accrued for this study within 5.5 years.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 21 and under

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Creatinine normal for age OR
  • Glomerular filtration rate normal for age

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior biologic therapy

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • No prior endocrine therapy

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • See Disease Characteristics

Other:

  • No prior therapy except tumor resection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003994

  Show 159 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Howard M. Katzenstein, MD AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
Malogolowkin MH, Katzenstein H, Krailo MD, Chen Z, Bowman L, Reynolds M, Finegold M, Greffe B, Rowland J, Newman K, Womer RB, London WB, Castleberry RP. Intensified platinum therapy is an ineffective strategy for improving outcome in pediatric patients with advanced hepatoblastoma. J Clin Oncol. 2006 Jun 20;24(18):2879-84.
Malogolowkin MH, Katzenstein HM, Krailo MD, et al.: Complete surgical resection for children with pure fetal histology hepatoblastoma (PFH): A report of the Childrens Oncology Group. [Abstract] J Clin Oncol 26 (Suppl 15): A-10049, 2008.

Study ID Numbers: CDR0000067200, COG-P9645, POG-9645, CCG-P9645
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00003994     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I childhood liver cancer
recurrent childhood liver cancer
childhood hepatoblastoma

Study placed in the following topic categories:
Antimetabolites
Liver Diseases
Digestive System Neoplasms
Immunologic Factors
Amifostine
Adjuvants, Immunologic
Vincristine
Antimitotic Agents
Immunosuppressive Agents
Recurrence
 Liver Neoplasms
Digestive System Diseases
Cisplatin
Fluorouracil
Tubulin Modulators
Hepatocellular Carcinoma, Childhood
Gastrointestinal Neoplasms
Hepatoblastoma
Antineoplastic Agents, Phytogenic

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

ClinicalTrials.gov processed this record on July 02, 2009



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