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Completed

NCT Number: NCT00516945

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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Elizabeth Hospital

Hong Kong, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lamivudine

Drug

Primary outcomes

  1. incidence of chemotherapy interruptions

    Time frame: during chemotherapy of the study period

Secondary outcomes

  1. incidence of and survival free from hepatitis B reactivation

    Time frame: during and after chemotherapy of the study period

  2. HBeAg positive seroconversion and YMDD mutant development rates

    Time frame: during study period after chemotherapy

  3. chemotherapy dose intensity reduction due to hepatitis B reactivation

    Time frame: during chemotherapy of the study period

Sponsors and collaborators

Lead sponsor

Hospital Authority, Hong Kong

Other Gov

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2008
First posted
Aug 16, 2007
Registry last updated
Sep 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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