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
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Hospital Authority, Hong Kong.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Hospital Authority, Hong Kong
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT00516945
First received: August 15, 2007
Last updated: July 6, 2010
Last verified: July 2010
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Hepatitis B Neoplasms |
Drug: Lamivudine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Hospital Authority, Hong Kong:
Primary Outcome Measures:
- incidence of chemotherapy interruptions [ Time Frame: during chemotherapy of the study period ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 110 |
| Study Start Date: | September 2004 |
| Estimated Study Completion Date: | December 2007 |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00516945
Locations
| China | |
| Queen Elizabeth Hospital | |
| Hong Kong, China | |
Sponsors and Collaborators
Hospital Authority, Hong Kong
Investigators
| Principal Investigator: | Roger K C Ngan, Dr | Department of Clinical Oncology, Queen Elizabeth Hospital |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00516945 History of Changes |
| Other Study ID Numbers: | KC/KE04-0046/FR-2, HARECCTR0500016 |
| Study First Received: | August 15, 2007 |
| Last Updated: | July 6, 2010 |
| Health Authority: | Hong Kong: Ethics Committee |
Keywords provided by Hospital Authority, Hong Kong:
|
hepatitis B during cancer chemotherapy |
Additional relevant MeSH terms:
|
Neoplasms Hepatitis Hepatitis A Hepatitis B Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections |
DNA Virus Infections Lamivudine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on May 23, 2013