Clinical Trial: Combination Chemotherapy and Interferon Alfa-2b in Treating Patients With Nonmetastatic Liver Cancer That Cannot Be Removed by Surgery

Study Status: Withdrawn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

Official Title: A Phase II Trial of Oxaliplatin/Adriamycin/5 Fluorouracil in Continuous Infusion / Interferon α-2b (OXAFI) Combination as Neoadjuvant Therapy in Unresectable Non-Metastatic Hepatocellular Carcino

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, doxorubicin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Interferon alfa may interfere with the growth of tumor cells. Giving combination chemotherapy together with interferon alfa may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with interferon alfa-2b works in treating patients with nonmetastatic liver cancer that cannot be removed by surgery.


Detailed Summary:

OBJECTIVES:

Primary

  • Determine the response rate in patients with unresectable, nonmetastatic hepatocellular carcinoma treated with neoadjuvant oxaliplatin, doxorubicin hydrochloride, fluorouracil, and recombinant interferon alfa-2b.

Secondary

  • Determine the overall survival of patients treated with this regimen.
  • Determine the progression-free survival of patients treated with this regimen.
  • Determine the rate of conversion to resectability of tumor in patients treated with this regimen.
  • Determine the toxicity profile of this regimen in these patients.
  • Assess the quality of life of patients treated with this regimen.
  • Correlate changes in serological markers of angiogenesis before and after treatment with clinical outcome in these patients.
  • Correlate and validate the use of functional imaging before and after treatment with clinical outcome in these patients.

OUTLINE: Patients receive neoadjuvant OXAFI therapy comprising oxaliplatin IV and doxorubicin hydrochloride IV on days 1, 8 and 15; fluorouracil IV continuously on days 1-28; and recombinant interferon alfa-2b subcutaneously three times weekly in weeks 1-4. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients receive at least 2 courses of neoadjuvant therapy before undergoing evaluation for response. Patients whose disease becomes resectable after achieving a complete or
Sponsor: National Cancer Centre, Singapore

Current Primary Outcome: Objective tumor response rate as measured by RECIST criteria

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Serum VEGF levels
  • Tissue VEGF expression


Original Secondary Outcome: Same as current

Information By: National Cancer Institute (NCI)

Dates:
Date Received: May 8, 2007
Date Started: March 2007
Date Completion:
Last Updated: June 21, 2011
Last Verified: November 2008