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A Phase 1 Study of Sorafenib Integrated With Chemoembolization for Patients With Unresectable Hepatocellular Carcinoma


Phase 1
18 Years
N/A
Not Enrolling
Both
Hepatocellular Carcinoma, Liver Cancer, Localized Unresectable Liver Cancer

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Trial Information

A Phase 1 Study of Sorafenib Integrated With Chemoembolization for Patients With Unresectable Hepatocellular Carcinoma


PRIMARY OBJECTIVE:

I. To evaluate the toxicity and safety of integrating sorafenib with chemoembolization for
unresectable hepatocellular carcinoma.

SECONDARY OBJECTIVE:

I. To observe the imaging response (AASLD/EASL modification of RECIST) and time to
progression following chemoembolization in conjunction with sorafenib.

OUTLINE:

Patients receive oral sorafenib tosylate twice daily. Beginning 2 weeks later, patients
undergo chemoembolization with cisplatin, doxorubicin hydrochloride, and mitomycin C.

Chemoembolizaton repeats once a month for up to 4 procedures in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 4 weeks and then every 3
months.

Inclusion Criteria


Inclusion

- Histologically confirmed hepatocellular carcinoma

- AND/OR Magnetic Resonance Imaging (MRI) or Computerized Tomography (CT) consistent
with liver cirrhosis AND at least one solid liver lesion > 2cm with arterial-phase
enhancement and delayed washout regardless of alpha-feto protein levels (AFP)

- AND/OR AFP > 400ng/mL AND evidence of at least one solid liver lesion > 2cm
regardless of specific imaging characteristics on CT or MRI

- Patient is not a candidate for transplantation, resection, or ablation; for whom the
intended therapy is chemoembolization

- Patient meets clinical criteria for treatment with chemoembolization

- Absolute contraindications to chemoembolization include an uncorrectable bleeding
disorder, uncorrectable contrast sensitivity, leukopenia (white blood cell count <
1000/uL), cardiac or renal insufficiency (serum creatinine > 2.0mg/dL), hepatic
encephalopathy, jaundice, or dilated intrahepatic bile ducts

- Portal vein occlusion is a relative contraindication and chemoembolization can be
performed only if there are collateral vessels with hepato-pedal flow demonstrated
angiographically

- Hepatic compromise as determined by the following combination of parameters is a
contraindication to therapy: lactate dehydrogenase > 425 U/L, aspartate
aminotransferase > 100 U/L, total bilirubin > 2.0 mg/dL and > 50% liver volume
replaced by tumor

- Patients may have been treated with ablation or resection in the past, but no sooner
than 4 weeks before study registration

- Patients may NOT have been previously treated with sorafenib, chemoembolization,
radioembolization, or systemic chemotherapy with cytotoxic agents or molecularly
targeted agents

- ECOG performance status =< 2

- Life expectancy of greater than 3 months

- Platelets >= 50,000/mcL

- Total bilirubin =< 2.0 mg/dl

- AST(SGOT)/ALT(SGPT) =< 3X institutional upper limit of normal

- Creatinine =< 1.5 mg/dl

- INR =< 1.5

- Patients must have no clinical signs of heart failure and meet New York Heart
Association functional classification I or II defined as:

Class I - Patients with no limitation of activities; they suffer no symptoms from ordinary
activities; Class II - Patients with slight, mild limitation of activity; they are
comfortable with rest or with mild exertion

- Because agents used in this trial are known to be teratogenic, women of child-bearing
potential and men must agree to use adequate contraception (hormonal or barrier
method of birth control; abstinence) prior to study entry and for the duration of
study participation

- Should a woman become pregnant or suspect she is pregnant while participating in this
study, she should inform her treating physician immediately

- Ability to understand and the willingness to sign a written informed consent document

Exclusion

- Patients may not be receiving any other investigational agents

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to sorafenib

- History of radiologic contrast reactions not controlled by standard premedications

- Patients must not be taking cytochrome P450 enzyme inducing drugs

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, uncontrolled hypertension, or psychiatric illness/social situations that
would limit compliance with study requirements

- Pregnant women are excluded from this study

- Breastfeeding should be discontinued

- Prophylactic use of G-CSF or GM-CSF is not permitted on this trial

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Dose adjustment, number and percentage of subjects with adverse events, laboratory changes, number and percentage of subjects with laboratory values that are outside the pre-determined ranges, cumulative toxicity, and TLT.

Outcome Time Frame:

8 months

Safety Issue:

Yes

Principal Investigator

Michael Soulen

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

United States: Institutional Review Board

Study ID:

UPCC 08208

NCT ID:

NCT01042041

Start Date:

September 2009

Completion Date:

December 2010

Related Keywords:

  • Hepatocellular Carcinoma
  • Liver Cancer
  • Localized Unresectable Liver Cancer
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

Name

Location

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283