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Sponsored by: |
National Cancer Centre, Singapore |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00471484 |
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.
Condition | Intervention | Phase |
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Liver Cancer |
Biological: recombinant interferon alfa-2b Drug: doxorubicin hydrochloride Drug: fluorouracil Drug: oxaliplatin Other: immunoenzyme technique Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: adjuvant therapy Procedure: biopsy Procedure: conventional surgery Procedure: neoadjuvant therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
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 Carcinoma |
Estimated Enrollment: | 54 |
Study Start Date: | March 2007 |
OBJECTIVES:
Primary
Secondary
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 partial response proceed to surgery. Patients whose disease remains unresectable are reevaluated until their disease either becomes resectable, they complete neoadjuvant therapy, or they meet discontinuation criteria.
At least 2 weeks after receiving neoadjuvant therapy, patients whose disease is resectable undergo surgery for potentially complete resection of their tumors with curative intent. Patients who achieve complete resection proceed to adjuvant therapy.
At least 4 weeks after surgery, patients may restart OXAFI as adjuvant therapy, provided they have fully recovered from surgery and have received fewer than 6 courses of neoadjuvant therapy. Adjuvant therapy repeats every 28 days for a total of 6 courses (including neoadjuvant OXAFI) in the absence of disease progression or unacceptable toxicity.
Patients undergo blood and tissue collection at baseline and periodically during study for evaluation of circulating and tissue biomarkers of angiogenesis. Serum from venous blood samples is analyzed for concentration of VEGF by ELISA. Tumor tissue obtained before and after treatment is examined for tumor VEGF expression, microvessel density, and cellular proliferation by IHC.
Patients complete quality of life questionnaires at baseline, monthly during study treatment, after course 6 of neoadjuvant chemotherapy, or upon discontinuation of study treatment.
Patients are followed periodically for up to 5 years after curative resection of their tumors.
PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.
Ages Eligible for Study: | 16 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed hepatocellular carcinoma
PATIENT CHARACTERISTICS:
Hepatitis B surface antigen (HBsAg) status known
No concurrent uncontrolled illness including, but not limited to, any of the following:
No psychiatric illness or social situation that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Singapore | |
National Cancer Centre - Singapore | Recruiting |
Singapore, Singapore, 169610 | |
Contact: Donald Poon, MD 65-6-436-8000 |
Study Chair: | Donald Poon, MD | National Cancer Centre, Singapore |
Investigator: | Kian Fong Foo, MD | National Cancer Centre, Singapore |
Study ID Numbers: | CDR0000543536, SINGAPORE-OC-GI-01-06, SINGAPORE-IRB-06-16-HEP, SINGAPORE-CTC0600327, SPRI-SINGAPORE-OC-GI-01-06 |
Study First Received: | May 8, 2007 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00471484 History of Changes |
Health Authority: | Unspecified |
adult primary hepatocellular carcinoma localized unresectable adult primary liver cancer advanced adult primary liver cancer |
Antimetabolites Liver Diseases Interferon Type I, Recombinant Immunologic Factors Carcinoma, Hepatocellular Liver Neoplasms Anti-Bacterial Agents Oxaliplatin Hepatocellular Carcinoma Interferon-alpha Digestive System Neoplasms Interferons Adjuvants, Immunologic |
Antiviral Agents Angiogenesis Inhibitors Immunosuppressive Agents Doxorubicin Carcinoma Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Interferon Alfa-2a Adenocarcinoma Interferon Alfa-2b Neoplasms, Glandular and Epithelial |
Antimetabolites Anti-Infective Agents Liver Diseases Interferon Type I, Recombinant Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Carcinoma, Hepatocellular Physiological Effects of Drugs Antibiotics, Antineoplastic Liver Neoplasms Oxaliplatin Neoplasms by Site Therapeutic Uses |
Growth Inhibitors Angiogenesis Modulating Agents Interferon-alpha Digestive System Neoplasms Neoplasms by Histologic Type Growth Substances Interferons Immunosuppressive Agents Angiogenesis Inhibitors Antiviral Agents Doxorubicin Pharmacologic Actions Carcinoma Neoplasms Digestive System Diseases |