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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2008-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis B Neoplasms

Keywords

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hepatitis B during cancer chemotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Lamivudine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Roger K C Ngan, Dr

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Oncology, Queen Elizabeth Hospital

Locations

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Queen Elizabeth Hospital

Hong Kong, , China

Site Status

Countries

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China

Other Identifiers

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HARECCTR0500016

Identifier Type: -

Identifier Source: secondary_id

KC/KE04-0046/FR-2