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Phase II Study of Sorafenib Plus Doxorubicin in Patients With Advanced Hepatocellular Carcinoma With Disease Progression on Sorafenib


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

Phase II Study of Sorafenib Plus Doxorubicin in Patients With Advanced Hepatocellular Carcinoma With Disease Progression on Sorafenib


Inclusion Criteria:



- Diagnosis of HCC confirmed histologically.

- Prior treatment with sorafenib as single agent or in combination, with no less than
200 mg once every other day dose of sorafenib, with radiologic evidence of
progression of disease.

- Measurable disease using RECIST 1.1 criteria.

- Non-cirrhotic or no more than Child-Pugh A cirrhosis.

- Expected survival of at least 3 months.

- Age ≥ 18 years.

- KPS ≥ 70%

- Fully recovered from any prior surgery and/or radiation and none within 2 weeks of
initiating treatment.

- Patients may have been treated with locoregional liver directed therapies such as
embolization, chemo-embolization including drug-eluting beads doxorubicin
chemoembolization (prior non drug eluting beads chemoembolization with doxorubicin is
excluded), radiation, radioactive microspheres, etc., provided that they either have
a target lesion that has not been subjected to local therapy and/or the target
lesion(s) within the field of the local therapy has shown an increase of ≥25% in the
size since last treatment. Such therapy must be completed at least 4 weeks prior to
registration. Patients that have received palliative radiation therapy to the bone
need not wait 4 weeks to begin protocol therapy.

- Informed consent must be obtained prior to study initiation.

- Total bilirubin <3.0 mg/dL and no evidence of bile obstruction.

- Absolute neutrophil count (ANC) >1,500/μL.

- Platelets >75,000/μL.

- Serum creatinine ≤ 1.5 x the upper limit of normal range, or, if serum creatinine
>1.5 x the upper limit of normal range, then the creatinine clearance must be ≥ 60
mL/min.

- Subjects with active hepatitis B or C on anti-viremic compounds may remain on such
treatment, except for interferon.

- Patients with a history of hypertension should be well controlled (< 140/90 mmHg) on
a regimen of anti-hypertensive therapy.

- Brain metastases are allowed if well controlled and without seizures.

- Prior palliative radiation therapy to bone sites is allowed as long as it is
completed within more than two weeks

Exclusion Criteria:

- Significant cardiac disease:

- Congestive heart failure > Class II New York Heart Association (NYHA).

- Myocardial infarction within 6 months prior to study entry.

- Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or
digoxin.

- Serious myocardial dysfunction, defined as scintigraphically (MUGA, myocardial
scintigram) or echocardiogram determined absolute left ventricular ejection fraction
(LVEF) below normal

- Participation in concurrent investigational studies.

- Prior loco-regional therapy including drug-eluting beads doxorubicin
chemoembolization (prior non drug eluting beads chemoembolization with doxorubicin is
excluded) is allowed.

- Prior exposure to systemic intravenously given doxorubicin.

- Pregnancy or lactation.

- Uncontrolled inter-current illness or psychiatric illness or social situations that
would limit compliance with study requirements.

- Subjects with history of another primary cancer, with the exception of: a) curatively
resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ;
or c) other primary solid tumor with no known active disease present in the opinion
of the investigator will not affect patient outcome in the setting of current HCC
diagnosis. Allografts, including but not limited to liver and bone marrow
transplants.

- Bleeding esophageal or gastric varices within the prior 30 days Concomitant treatment
with Rifampin or St John's Wort. Patients should discontinue these drugs at least 4
weeks prior to starting protocol treatment.

- Subjects known to be HIV positive.

- History of bleeding diathesis.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Ghassan Abou-Alfa, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

12-259

NCT ID:

NCT01840592

Start Date:

April 2013

Completion Date:

April 2015

Related Keywords:

  • Hepatocellular Carcinoma
  • Liver
  • Sorafenib
  • Doxorubicin
  • 12-259
  • Carcinoma
  • Disease Progression
  • Carcinoma, Hepatocellular

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021