Clinical trial 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
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
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis B
Neoplasms
Keywords: hepatitis B during cancer chemotherapy
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
First posted: 2007-08-16
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: incidence of chemotherapy interruptions
timeFrame: during chemotherapy of the study period
Secondary outcomes:
measure: incidence of and survival free from hepatitis B reactivation
timeFrame: during and after chemotherapy of the study period
measure: HBeAg positive seroconversion and YMDD mutant development rates
timeFrame: during study period after chemotherapy
measure: chemotherapy dose intensity reduction due to hepatitis B reactivation
timeFrame: during chemotherapy of the study period
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Queen Elizabeth Hospital
Study officials:
affiliation: Department of Clinical Oncology, Queen Elizabeth Hospital
name: Roger K C Ngan, Dr
role: PRINCIPAL_INVESTIGATOR
References: