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

Completed · Phase 3

Conditions studied: Childhood Hepatoblastoma, Recurrent Childhood Liver Cancer, Stage I Childhood Liver Cancer

In brief

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.

Key facts

Study ID

NCT00003994

Run by

Children's Oncology Group

People needed

277

Starts

1999-03-01

Last updated by the study team

2013-06-14

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• Children's Oncology Group — Arcadia, California, United States

Full record on ClinicalTrials.gov

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