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Drug Monitoring of Sorafenib in Patients With Advanced Hepatocellular Carcinoma (DOSE-HEP)

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ClinicalTrials.gov Identifier: NCT01078311
Recruitment Status : Unknown
Verified February 2010 by South West Sydney Local Health District.
Recruitment status was:  Recruiting
First Posted : March 2, 2010
Last Update Posted : March 2, 2010
Sponsor:
Information provided by:
South West Sydney Local Health District

Study Description
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Brief Summary:
Sorafenib improves overall survival and progression free survival in advanced hepatocellular carcinoma. Wide interindividual pharmacokinetic variability was observed. Data from early phase trials in solid tumours showed trough sorafenib levels were associated with incidence of skin rash and hypertension. Rash, hypertension and higher trough levels were moderately predictive of progression free survival.The trough level of sorafenib may be predictive of survival and response in patients treated with sorafenib for advanced hepatocellular carcinoma.

Condition or disease
Hepatocellular Cancer

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase 2 Study of Measurement of Trough Levels of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
Study Start Date : February 2010
Estimated Primary Completion Date : February 2012
Estimated Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Groups and Cohorts
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Group/Cohort
HCC patients on Sorafenib


Outcome Measures
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Primary Outcome Measures :
  1. To demonstrate the correlation of trough sorafenib level with overall survival in advanced hepatocellular carcinoma [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. To correlate trough sorafenib level with progression free survival [ Time Frame: 4 years ]
  2. To correlate trough sorafenib level with response (disease-control vs progressive disease) by RECIST criteria [ Time Frame: 4 years ]
  3. To correlate trough sorafenib level with alpha fetoprotein (AFP) response [ Time Frame: 4 years ]
  4. To correlate trough sorafenib level with side effects (rash and hypertension) [ Time Frame: 4 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with advanced HCC who are to commence Sorafenib
Criteria

Inclusion Criteria:

  • ECOG ≤ 2
  • Histologically or cytologically diagnosed hepatocellular carcinoma, or diagnosis on at least one cross-sectional imaging with the characteristic appearance of HCC (i.e. liver lesion with arterial enhancement and portal venous washout)
  • Decision to treat with single agent sorafenib at 400mg bid (dose reductions or interruptions are permitted if side effects occur during treatment)
  • No prior systemic chemotherapy or targeted therapy
  • Child-Pugh liver function class A or B
  • At least one untreated target lesion that can be measured in one dimension according to RECIST
  • Adequate organ functions

Exclusion Criteria:

  • Prior systemic chemotherapy or molecularly targeted therapy
  • Concurrent active malignancy
  • Concomitant strong CYP3A4 induced or inhibitor at a therapeutic dose (see section 6.4.1)
  • Medical or psychiatric conditions that compromise the patient's ability to give informed consent
  • Hypertension that cannot be controlled by medications (> 150/100 mmHg despite optimal medical therapy)
  • History of, or known brain metastases (skull metastases allowed), carcinomatous meningitis, or leptomenigeal disease
  • Major surgery (e.g. open abdominal therapy, pelvic, thoracic, orthopaedic or neurosurgery) within 4 weeks of the date of first dose
  • Local-regional treatment (i.e. percutaneous and trans-arterial procedures) within 4 weeks. Restaging CT or MRI scan must be repeated at least 4 weeks after local-regional treatment and within 3 weeks before the date of first dose
  • For patients treated with Yttrium (90Y) radiotherapy, a washout period of 2 months is required.
  • Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol
  • Pregnancy or breast feeding
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01078311


Contacts
Contact: Mark Wong, MBBS, FRACP 61298455200 ext 55200 Mark.Wong@swahs.health.nsw.gov.au

Locations
Australia, New South Wales
Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Sponsors and Collaborators
South West Sydney Local Health District
More Information
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Responsible Party: Mark Wong, Westmead Medical Oncology
ClinicalTrials.gov Identifier: NCT01078311     History of Changes
Other Study ID Numbers: MWWH009
First Posted: March 2, 2010    Key Record Dates
Last Update Posted: March 2, 2010
Last Verified: February 2010

Keywords provided by South West Sydney Local Health District:
Patients with advanced hepatocellular cancer

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action