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 - Full Text View

Purpose

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.

Condition	Intervention
Hepatitis B Neoplasms	Drug: Lamivudine

MedlinePlus related topics:

Cancer Hepatitis Hepatitis B

ChemIDplus related topics:

Lamivudine Hepatitis B Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Official Title:	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

Further study details as provided by Hospital Authority, Hong Kong:

Primary Outcome Measures:

incidence of chemotherapy interruptions [ Time Frame: during chemotherapy of the study period ]

Secondary Outcome Measures:

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

Estimated Enrollment:	110
Study Start Date:	September 2004
Estimated Study Completion Date:	December 2007

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00516945

Locations


China
	Queen Elizabeth Hospital
	Hong Kong, China

Sponsors and Collaborators

Hospital Authority, Hong Kong

Investigators


Principal Investigator:	Roger K C Ngan, Dr	Department of Clinical Oncology, Queen Elizabeth Hospital

More Information

HAREC Clinical Trial Registry This link exits the ClinicalTrials.gov site

Study ID Numbers:	KC/KE04-0046/FR-2, HARECCTR0500016
First Received:	August 15, 2007
Last Updated:	June 17, 2008
ClinicalTrials.gov Identifier:	NCT00516945
Health Authority:	Hong Kong: Ethics Committee

Keywords provided by Hospital Authority, Hong Kong:

hepatitis B during cancer chemotherapy

Study placed in the following topic categories:

Virus Diseases

Hepatitis

Liver Diseases

Digestive System Diseases

Hepatitis B

Lamivudine

Hepatitis, Viral, Human

DNA Virus Infections

Additional relevant MeSH terms:

Anti-Infective Agents

Neoplasms

Anti-HIV Agents

Anti-Retroviral Agents

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Enzyme Inhibitors

Antiviral Agents

Hepadnaviridae Infections

Pharmacologic Actions

Nucleic Acid Synthesis Inhibitors

Reverse Transcriptase Inhibitors

ClinicalTrials.gov processed this record on October 07, 2008

Sponsored by:	Hospital Authority, Hong Kong
Information provided by:	Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:	NCT00516945