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

Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00516945
• Other study ID #: KC/KE04-0046/FR-2
• Secondary ID: HARECCTR0500016
• Status: Completed
• Phase: N/A
• First received: August 15, 2007
• Last updated: September 3, 2013
• Start date: September 2004
• Est. completion date: June 2008

Study information

• Verified date: July 2013
• Source: Hospital Authority, Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: June 2008
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Neoplasms

Intervention

Drug:
• Lamivudine

Locations

Country	Name	City	State
China	Queen Elizabeth Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Authority, Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of chemotherapy interruptions		during chemotherapy of the study period
Secondary	incidence of and survival free from hepatitis B reactivation		during and after chemotherapy of the study period
Secondary	HBeAg positive seroconversion and YMDD mutant development rates		during study period after chemotherapy
Secondary	chemotherapy dose intensity reduction due to hepatitis B reactivation		during chemotherapy of the study period

External Links

•   HAREC Clinical Trial Registry