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Study of Sorafenib and Gemcitabine in Advanced Hepatocellular Carcinoma (HCC)

NCT00844688 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2009-02-16

No results posted yet for this study

Summary

For the majority of patients, metastatic HCC is incurable and patients should be considered candidates for clinical trials when appropriate. Till recently there was no worldwide, approved local or systemic therapy for advanced HCC and the available therapies for advanced unresectable and/or metastatic HCC have limited clinical values, with low response rates and little impact on the natural history of the disease. Furthermore, the toxicities associated with these agents can be severe, requiring careful patient selection, and this dramatically decreases the number of patients who may benefit from therapy. The SHARP trial established the survival benefit of Sorafenib in Advanced HCC but the results yet remain humble. The need for more effective therapies is still there.

Study Objectives

The primary objective of this phase II study is to evaluate the efficacy and safety of Sorafenib and Gemcitabine combination in patients with advanced HCC.

Safety data and limited efficacy data will be collected for this combination in the study. All Drug-Related Adverse Events, all Adverse Events NCI CTCAE Version 3.0 Grade 3 or higher, and all Serious Adverse Events regardless of causal relationship to study drugs will be recorded in this study.

Conditions

Interventions

DRUG

sorafenib

Patients will be treated with 400 mg oral sorafenib twice a day on a continuous basis. Patients in this protocol may continue to be treated with this combination for a minimum of 4 cycles until any of the following criteria for protocol discontinuation is reached: 1. Progression of disease. 2. The patient is unlikely to benefit from further treatment as Judged by the Investigator. 3. Intolerable toxicity of the drugs. 4. Withdrawal of consent for any reason.

DRUG

Gemcitabine

Patients will be treated with Gemcitabine 1000mg/m2 administered on day 1 \& 8 of a 4 week cycle. Patients in this protocol may continue to be treated with this combination for a minimum of 4 cycles until any of the following criteria for protocol discontinuation is reached: Progression of disease. The patient is unlikely to benefit from further treatment as Judged by the Investigator. Intolerable toxicity of the drugs. Withdrawal of consent for any reason.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Combined Military Hospital, Pakistan

    lead OTHER

Principal Investigators

  • Naeem Naqi, MBBS,FCPS · Consultant Oncologist

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-10-31
Completion
2009-12-31

Countries

  • Pakistan

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00844688 on ClinicalTrials.gov