Combination Chemotherapy With or Without Amifostine in Treating Young Patients With Liver Cancer
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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 3 |
| Study Type: | Interventional |
| 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 ]
| Estimated Enrollment: | 356 |
| Study Start Date: | March 1993 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
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 |
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
Show 159 Study Locations| 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:
Publications:
| ClinicalTrials.gov Identifier: | NCT00003994 History of Changes |
| Other Study ID Numbers: | CDR0000067200, COG-P9645, POG-9645, CCG-P9645 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 22, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage I childhood liver cancer recurrent childhood liver cancer childhood hepatoblastoma |
Additional relevant MeSH terms:
|
Liver Neoplasms Hepatoblastoma Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Liver Diseases Neoplasms, Complex and Mixed Neoplasms by Histologic Type Cisplatin Fluorouracil Vincristine Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 21, 2013