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

NCT00516945 | Completed

• 2 other identifiers: KC/KE04-0046/FR-2HARECCTR0500016
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatitis B; Neoplasms

Keywords

hepatitis B during cancer chemotherapy

Outcome Measures

Primary Outcomes (1)

• incidence of chemotherapy interruptions

  during chemotherapy of the study period

Secondary Outcomes (3)

• 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

Interventions

Lamivudine DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with histology-proven malignant solid tumor other than malignant lymphoma
• Patients with age between 18 and 75
• Patients with Karnofsky performance score (KPS) of at least 60
• 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
• Patients with at least 6 months' life expectany from date of recruitment
• Patients with normal liver function tests including alanine aminpotransferase (ALT), alkaline phosphatase (ALP), gamma glutamyl-transpeptidase (GGT), and bilirubin
• 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
• Patients with no evidence of autoimmune hepatitis, hepatitis C or delta virus infection, HIV infection or radiological evidence of liver metastasis
• Patients with negative pregnancy test for female gender of child-bearing age

You may not qualify if:

• Patients with age \< 18 and \> 75
• Patients with Karnofsky performance score (KPS) of \< 60
• Patients planned for single agent cisplatin chemotherapy alone concurrently with radiation for radiosensitization
• Patients with \< 6 months' life expectancy from date of recruitment
• Patients with abnormal liver function tests including alanine aminotransferase (ALT), alkaline phosphatase (ALP), gamma glutamyl- transpeptidase (GGT), and bilirubin
• 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
• Patients with autoimmune hepatitis, hepatitis C or delta virus infection, HIV infection or radiological evidence of liver metastasis
• pregnant female patients

Sponsors & Collaborators

• Hospital Authority, Hong Kong: lead

Study Sites (1)

Queen Elizabeth Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Hepatitis B; Neoplasms

Interventions

Lamivudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Officials

• Roger K C Ngan, Dr

  Department of Clinical Oncology, Queen Elizabeth Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: August 15, 2007
• First Posted: August 16, 2007
• Study Start: September 1, 2004
• Study Completion: June 1, 2008
• Last Updated: September 5, 2013

Record last verified: 2013-07

Locations

CN (1)