A Study to Investigate Whether the Immediate Use or Deferred Use of an Anti-viral Drug Lamivudine Will Help to Better Safe-guard the Delivery of Chemotherapy in Patients With Cancer Who Are Also Hepatitis B Carriers

A Randomized Controlled Study Comparing the Impact of Prophylactic Versus Deferred Lamivudine on the Delivery of Cytotoxic Chemotherapy in Hepatitis B Surface-antigen Positive Patients With Malignant Solid Tumor

Patients with non-lymphoma and non-leukaemia cancer who are also hepatitis B carriers will have a risk of hepatitis B reactivation during chemotherapy. Lamivudine can be used effectively to control hepatitis upon reactivation during chemotherapy and the chemotherapy may not need to be interrupted. The study aims to investigate whether adding the anti-viral drug Lamivudine at the start of chemotherapy for all patients, rather than at the time of hepatitis reactivation for those with reactivation, will help to improve the delivery of chemotherapy in these patients.

Study Overview

• Status: Completed
• Conditions: Neoplasms; Hepatitis B
• Intervention / Treatment: Drug: Lamivudine

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • Queen Elizabeth Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient with histology-proven malignant solid tumor other than malignant lymphoma
2. Patients with age between 18 and 75
3. Patients with Karnofsky performance score (KPS) of at least 60
4. Patients planned for at least 4 cycles of intensive cytotoxic chemotherapy (either as part of curative therapy or as palliative therapy), except for those receiving single agent cisplatin chemotherapy alone concurrently with radiation for radiosensitization
5. Patients with at least 6 months' life expectany from date of recruitment
6. Patients with normal liver function tests including alanine aminpotransferase (ALT), alkaline phosphatase (ALP), gamma glutamyl-transpeptidase (GGT), and bilirubin
7. Patients with no known history of radiological &/or histological diagnosis of chronic active hepatitis or cirrhosis of any cuase, or history of prior hepatitis B reactivation, or prior chronic therapy for HBV within 6 months
8. Patients with no evidence of autoimmune hepatitis, hepatitis C or delta virus infection, HIV infection or radiological evidence of liver metastasis
9. Patients with negative pregnancy test for female gender of child-bearing age

Exclusion Criteria:

1. Patients with age < 18 and > 75
2. Patients with Karnofsky performance score (KPS) of < 60
3. Patients planned for single agent cisplatin chemotherapy alone concurrently with radiation for radiosensitization
4. Patients with < 6 months' life expectancy from date of recruitment
5. Patients with abnormal liver function tests including alanine aminotransferase (ALT), alkaline phosphatase (ALP), gamma glutamyl- transpeptidase (GGT), and bilirubin
6. Patients with known history or radiological and/or histological diagnosis of chronic active hepatitis or cirrhosis of any cause, or history of prior hepatitis B reactivation, or prior chronic therapy for HBV within 6 months
7. Patients with autoimmune hepatitis, hepatitis C or delta virus infection, HIV infection or radiological evidence of liver metastasis
8. pregnant female patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
incidence of chemotherapy interruptions	during chemotherapy of the study period

Secondary Outcome Measures

Outcome Measure	Time Frame
incidence of and survival free from hepatitis B reactivation	during and after chemotherapy of the study period
HBeAg positive seroconversion and YMDD mutant development rates	during study period after chemotherapy
chemotherapy dose intensity reduction due to hepatitis B reactivation	during chemotherapy of the study period

Collaborators and Investigators

• Sponsor: Hospital Authority, Hong Kong
• Investigators: Principal Investigator: Roger K C Ngan, Dr, Department of Clinical Oncology, Queen Elizabeth Hospital

Publications and helpful links

Helpful Links

• HAREC Clinical Trial Registry

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: August 15, 2007
• First Submitted That Met QC Criteria: August 15, 2007
• First Posted (Estimate): August 16, 2007

Study Record Updates

• Last Update Posted (Estimate): September 5, 2013
• Last Update Submitted That Met QC Criteria: September 3, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: hepatitis B during cancer chemotherapy
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis B; Hepatitis; Hepatitis A; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Lamivudine
• Other Study ID Numbers: KC/KE04-0046/FR-2; HARECCTR0500016