Clinical Trial: Combination Chemotherapy and Thalidomide in Treating Younger Patients Undergoing Surgery For Newly Diagnosed Liver Cancer

Study Status: Withdrawn
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Hepatocellular Carcinoma Family of Tumours In Children / Adolescents and Young Adults

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as cisplatin and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Thalidomide may stop the growth of liver cancer by blocking blood flow to the tumor. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. Giving combination chemotherapy, thalidomide, and chemoembolization before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving thalidomide together with chemotherapy after surgery may kill any remaining tumor cells and prevent the tumor from coming back.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy and thalidomide together with chemoembolization works in treating younger patients undergoing surgery for newly diagnosed liver cancer.


Detailed Summary:

OBJECTIVES:

Primary

  • Determine the event-free and overall survival of younger patients undergoing surgery for newly diagnosed, noncirrhotic hepatocellular carcinoma (HCC) treated with neoadjuvant cisplatin, doxorubicin hydrochloride, and thalidomide (PLADOTH) followed by transarterial hepatic arterial chemoembolization comprising cisplatin and doxorubicin hydrochloride and adjuvant cyclophosphamide and thalidomide.
  • Determine the efficacy and tolerability of PLADOTH in patients with initially unresectable noncirrhotic HCC treated with this regimen.
  • Determine the rate of complete surgical resection by encouragement of liver transplantation in the treatment strategy as a valid option for tumor removal when partial liver resection or other surgical options remain unfeasible for patients treated with this regimen.
  • Determine the long-term remission and decreased relapse rates of patients treated with this regimen based on the postoperative regimen.

Secondary

  • Determine the response rate of patients treated with this regimen after treatment with PLADOTH.
  • Determine the short-term toxicity and feasibility of PLADOTH in patients treated with this regimen.
  • Determine the efficacy and toxicity of the postoperative regimen in terms of maintenance and duration of complete remission (no more evidence of disease and normal alpha-fetoprotein, if initially elevated) in patients treated with this regimen.
  • Determine whether response to PLADOTH by the RECIST criteria can b
    Sponsor: Children's Cancer and Leukaemia Group

    Current Primary Outcome: Event-free and overall survival following tumor resection

    Original Primary Outcome:

    Current Secondary Outcome: Efficacy and tolerability following course 2 and 4 of pre-operative chemotherapy

    Original Secondary Outcome:

    Information By: National Cancer Institute (NCI)

    Dates:
    Date Received: January 12, 2006
    Date Started: June 2005
    Date Completion:
    Last Updated: September 16, 2013
    Last Verified: June 2009