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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

Primary Purpose

Hepatitis B, Neoplasms

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Lamivudine

About this trial

This is an interventional treatment trial for Hepatitis B focused on measuring hepatitis B during cancer chemotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All Sexes

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

Sites / Locations

Queen Elizabeth Hospital

Outcomes

Primary Outcome Measures

incidence of chemotherapy interruptions

Secondary Outcome Measures

incidence of and survival free from hepatitis B reactivation

HBeAg positive seroconversion and YMDD mutant development rates

chemotherapy dose intensity reduction due to hepatitis B reactivation

Full Information

NCT ID

NCT00516945

First Posted

August 15, 2007

Last Updated

September 3, 2013

Sponsor

Hospital Authority, Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT00516945

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Completed

Study Start Date

September 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Hospital Authority, Hong Kong

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis B, Neoplasms

Keywords

hepatitis B during cancer chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Lamivudine

Primary Outcome Measure Information:

Title

incidence of chemotherapy interruptions

Time Frame

during chemotherapy of the study period

Secondary Outcome Measure Information:

Title

incidence of and survival free from hepatitis B reactivation

Time Frame

during and after chemotherapy of the study period

Title

HBeAg positive seroconversion and YMDD mutant development rates

Time Frame

during study period after chemotherapy

Title

chemotherapy dose intensity reduction due to hepatitis B reactivation

Time Frame

during chemotherapy of the study period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roger K C Ngan, Dr

Organizational Affiliation

Department of Clinical Oncology, Queen Elizabeth Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Queen Elizabeth Hospital

City

Hong Kong

Country

China

12. IPD Sharing Statement

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