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

This study has been completed.
Sponsor:
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT00516945
First received: August 15, 2007
Last updated: September 3, 2013
Last verified: July 2013

August 15, 2007
September 3, 2013
September 2004
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incidence of chemotherapy interruptions [ Time Frame: during chemotherapy of the study period ]
Same as current
Complete list of historical versions of study NCT00516945 on ClinicalTrials.gov Archive Site
  • incidence of and survival free from hepatitis B reactivation [ Time Frame: during and after chemotherapy of the study period ]
  • HBeAg positive seroconversion and YMDD mutant development rates [ Time Frame: during study period after chemotherapy ]
  • chemotherapy dose intensity reduction due to hepatitis B reactivation [ Time Frame: during chemotherapy of the study period ]
Same as current
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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
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

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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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatitis B
  • Neoplasms
Drug: Lamivudine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
June 2008
Not Provided

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
Both
18 Years to 75 Years
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Contact information is only displayed when the study is recruiting subjects
China
 
NCT00516945
KC/KE04-0046/FR-2, HARECCTR0500016
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Hospital Authority, Hong Kong
Not Provided
Principal Investigator: Roger K C Ngan, Dr Department of Clinical Oncology, Queen Elizabeth Hospital
Hospital Authority, Hong Kong
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP