Combination Chemotherapy With or Without Amifostine in Treating Young Patients With Liver Cancer
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.
Drug: vincristine sulfate
Procedure: adjuvant therapy
Procedure: conventional surgery
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Intergroup Protocol for Treatment of Children With Hepatoblastoma|
- 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 ]
|Study Start Date:||March 1993|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
- 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.
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|Study Chair:||Howard M. Katzenstein, MD||AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus|