Overview

This trial is active, not recruiting.

Condition liver cancer
Treatments carboplatin, cisplatin, doxorubicin hydrochloride, adjuvant therapy, conventional surgery, neoadjuvant therapy
Phase phase 2
Sponsor University of Leicester
Start date January 2004
Trial size 57 participants
Trial identifier NCT00077389, CCLG-LT-2004-09, CDR0000350221, EU-20336, SIOP-SIOPEL-4

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well neoadjuvant chemotherapy works in treating young patients who are undergoing surgical resection for high-risk hepatoblastoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Rate of complete remission after completion of study therapy
time frame:

Secondary Outcomes

Measure
Complete resection rate
time frame:
Response rate to preoperative chemotherapy
time frame:
Rate of grade 2 cardiac and renal, grade 3 otological, and grade 4 nonhematological toxicity as assessed during and after completion of study therapy
time frame:
Overall survival
time frame:
Event-free survival
time frame:

Eligibility Criteria

Male or female participants up to 17 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed hepatoblastoma - High-risk disease, meeting criteria for at least 1 of the following: - Tumor involving all 4 hepatic sections - Evidence of abdominal extrahepatic disease - Presence of metastases - Alpha-fetoprotein < 100 ng/mL at diagnosis - Must have had a prior diagnostic biopsy within the past 15 days - No recurrent disease PATIENT CHARACTERISTICS: Age - Under 18 Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - AST and/or ALT ≤ 3 times normal Renal - Glomerular filtration rate ≥ 60 mL/min Cardiovascular - Shortening fraction ≥ 29% OR - Ejection fraction ≥ 40% Other - Not pregnant - Negative pregnancy test - No pre-existing clinically relevant bilateral hearing loss - No other condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - No prior therapy for hepatoblastoma

Additional Information

Official title Intensified Pre-Operative Chemotherapy And Radical Surgery For High Risk Hepatoblastoma
Description OBJECTIVES: Primary - Determine the efficacy and short-term toxicity of intensified neoadjuvant chemotherapy in children with high-risk hepatoblastoma undergoing surgical resection. - Increase the rate of complete surgical resection in these patients by fully implementing liver transplantation as a valid treatment option for tumor removal when partial liver resection or other surgical options remain unfeasible even after extensive preoperative chemotherapy. - Determine, prospectively, the role of this regimen in rendering unresectable tumors resectable in these patients. - Determine the accuracy of initial imaging in predicting the surgical options (after treatment with this regimen) for patients presenting with unresectable disease. Secondary - Determine the overall survival and event-free survival of patients treated with this regimen (with an acceptable overall toxicity). - Determine the toxicity of this regimen in these patients. - Determine the response rate in patients treated with this regimen. - Determine whether response to this regimen, defined by the modified RECIST criteria, can be used for better monitoring of response in these patients. - Determine whether a fall in alpha-fetoprotein during this neoadjuvant regimen can be used as a prognostic factor in these patients. - Determine, prospectively, radiological, surgical, and pathological characteristics of the tumor that might identify possible novel factors that might influence treatment choice and outcome in these patients. OUTLINE: This is an open-label, multicenter study. - Intensified neoadjuvant chemotherapy: Patients receive cisplatin IV over 24 hours on days 1, 8, 15, 29, 36, 43, 57, and 64; and doxorubicin IV over 1 hour OR over 24 hours on days 8, 9, 36, 37, 57, and 58. Patients determined to have resectable disease proceed to surgery. Patients determined to have unresectable disease after neoadjuvant chemotherapy receive additional neoadjuvant chemotherapy comprising carboplatin IV over 1 hour on days 1 and 22 and doxorubicin IV over 1 hour OR over 24 hours on days 1, 2, 3, 22, 23, and 24. Treatment continues in the absence of unacceptable toxicity. - Surgery: Patients determined to have resectable disease undergo complete resection and possibly liver transplantation. - Adjuvant chemotherapy*: Patients who undergo complete surgical resection receive carboplatin IV over 1 hour on day 1 and doxorubicin IV over 1 hour OR over 24 hours on days 1 and 2. Treatment repeats every 3 weeks for a total of 3 courses. NOTE: *Patients who received additional neoadjuvant chemotherapy for unresectable disease do not receive adjuvant chemotherapy. Patients are followed every 2-3 months for 2 years, every 3 months for 1 year, and then every 6 months for 2 years. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 23-57 patients will be accrued for this study within 2 years.
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).