Status:
COMPLETED
Trial of Sorafenib in Hepatocellular Cancer (HCC) Transplant Patients
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Bayer
Amgen
Conditions:
Hepatocellular Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This Phase I study of sorafenib in high risk hepatocellular cancer patients after liver transplantation will study 24 subjects for about 5 years. Each subject will receive sorafenib for 6 months. Safe...
Detailed Description
Sorafenib (BAY 43-9006) is an oral multi-kinase inhibitor with effects on tumor proliferation and angiogenesis. Sorafenib is approved for the treatment of patients with advanced renal cancer and unres...
Eligibility Criteria
Inclusion
- Age ≥18 years old
- ECOG Performance Status 0-2
- Post liver transplant and have explants with histologically confirmed hepatocellular carcinoma.
- No evidence of HCC disease at study entry by imaging
- Eligible to start 4 weeks post transplant (29 days post transplant) as long as they are on stable doses of immunosuppressants.
- "High risk" for recurrence after transplantation
- Received prior surgical resection, chemoembolization or other local therapy prior to transplant.
- Have Child-Pugh Class A or compensated Child-Pugh Class B liver dysfunction at the start of therapy
- Have adequate bone marrow, liver and renal function as assessed by the following:
- Hemoglobin ≥ 8.0 g/dl
- Absolute neutrophil count (ANC) ≥ 1,500/mm3
- Platelet count ≥ 75,000/mm3
- Total bilirubin ≤ 1.5 times ULN
- ALT and AST ≤ 5 x ULN
- Creatinine ≤ 1.5 times ULN
- Albumin ≥ 2.5 mg/dl
- Women of childbearing potential must have a negative serum pregnancy test performed within 14 days prior to the start of treatment
- Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Men should use adequate birth control for at least three months after the last administration of sorafenib.
- Exhibit the ability to understand and willingness to sign a written informed consent regarding the study and alternative treatments.
- INR \< 1.5 or a PT/PTT within normal limits.
Exclusion
- Cardiac disease: Congestive heart failure \> class II NYHA.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
- Uncontrolled hypertension, defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management.
- Active clinically serious infection \> CTCAE Grade 2.
- Thromboembolic events such as a cerebrovascular accident (including transient ischemic attacks) within the past 6 months.
- Any hemorrhage/bleeding event ≥ CTCAE Grade 3 within 4 weeks of first dose of study drug.
- Serious non-healing wound, ulcer, or bone fracture within 4 weeks of first dose of study drug.
- Evidence or history of bleeding diathesis or coagulopathy within 4 weeks of first dose of study drug.
- Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
- Use of St. John's Wort or rifampin within 4 weeks of first dose of study drug.
- Known or suspected allergy to sorafenib or any agent given in the course of this trial.
- Any condition that impairs patient's ability to swallow whole pills.
- Patients who are pregnant or breastfeeding. Breastfeeding should be discontinued if the patient is to be treated.
- Prior malignancy treated during the prior 5-years (other than localized non-melanoma carcinoma of the skin).
- Any condition or social situation that may limit patient's compliance with the study regimen
- Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis prior to enrollment.
- Known human immunodeficiency virus (HIV) infection (hepatitis B and hepatitis C infection will not be exclusion criteria.
- Pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 2 within 4 weeks of first dose of study drug.
- Any malabsorption problem which in the investigator's opinion would prevent adequate absorption of the sorafenib.
- On M-Tor inhibitors
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00997022
Start Date
May 1 2009
End Date
May 1 2015
Last Update
August 10 2015
Active Locations (3)
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1
University of Southern California
Los Angeles, California, United States, 90089
2
University of California, Los Angeles
Los Angeles, California, United States, 90095
3
Columbia University Medical Center
New York, New York, United States, 10032