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Phase II Trial of Intrahepatic Artery Chemotherapy With Nexavar in Hepatocellular Carcinoma Patients


Phase 2
18 Years
N/A
Not Enrolling
Both
Liver Cancer

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Trial Information

Phase II Trial of Intrahepatic Artery Chemotherapy With Nexavar in Hepatocellular Carcinoma Patients


OBJECTIVES:

Primary

- To assess the safety of intrahepatic arterial infusion of cisplatin or carboplatin in
combination with sorafenib tosylate in patients with unresectable hepatocellular
carcinoma.

Secondary

- To assess the time to tumor progression in patients treated with this regimen.

- To assess the overall and progression-free survival of patients treated with this
regimen.

OUTLINE: Patients receive intrahepatic arterial infusion of cisplatin or carboplatin over
30-45 minutes on day 1 and oral sorafenib tosylate twice daily on days 8-35. Treatment
repeats every 42 days for up to 12 courses in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed hepatocellular carcinoma (HCC) OR serum alpha fetoprotein ≥
400 ng/mL with radiological evidence suggestive of HCC

- Unresectable disease

- Child-Pugh class A or selected Child-Pugh class B disease (Child-Pugh score ≤ 7
points)

- No Child-Pugh class C disease

- No disease outside the liver or macroscopic invasion of the major vessels such as the
portal vein

- No known brain metastasis

- Patients with neurological symptoms must undergo CT scan or MRI of the brain

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- WBC ≥ 3,000/mm³ (for patients scheduled to receive carboplatin) or ≥ 2,000/mm³ (for
patients scheduled to receive cisplatin)

- Platelet count ≥ 100,000/mm³ (for patients scheduled to receive carboplatin) or ≥
60,000/mm³ (for patients scheduled to receive cisplatin)

- Serum creatinine ≤ 1.9 mg/dL (for patients scheduled to receive carboplatin) or ≤ 1.5
mg/dL (for patients scheduled to receive cisplatin)

- Serum total bilirubin ≤ 3 mg/dL

- AST and ALT < 5 times upper limit of normal

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for ≥ 3 months after
completion of study treatment

- No cardiac disease, including any of the following:

- NYHA class III-IV congestive heart failure

- Unstable angina (anginal symptoms at rest)

- New onset of angina within the past 3 months

- Myocardial infarction within the past 6 months

- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

- No uncontrolled hypertension, defined as systolic BP > 150 mm Hg or diastolic BP > 90
mm Hg, despite optimal medical management

- No thrombolic or embolic events (e.g., cerebrovascular accident, including transient
ischemic attacks) within the past 6 months

- No pulmonary hemorrhage/bleeding event ≥ CTCAE grade 2 within the past 4 weeks

- No other hemorrhage/bleeding event ≥ CTCAE grade 3 within the past 4 weeks

- No evidence or history of bleeding diathesis or coagulopathy

- No evidence of encephalopathy

- No condition that would impair the ability to swallow whole pills

- No history of malabsorption problems

- No significant traumatic injury within the past 4 weeks

- No serious non-healing wound, ulcer, or bone fracture

- No active clinically serious infection

- No known HIV infection

- No known or suspected allergy to sorafenib tosylate or any other study agent

PRIOR CONCURRENT THERAPY:

- No prior cisplatin, carboplatin, or sorafenib tosylate

- No prior systemic chemotherapy for HCC

- No other prior systemic or locoregional therapy

- More than 4 weeks since prior major surgery or open biopsy

- No concurrent St. John's wort or rifampin

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety

Outcome Time Frame:

4 years

Safety Issue:

Yes

Principal Investigator

Lynn G. Feun, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

EPROST-20080793

NCT ID:

NCT00875615

Start Date:

December 2008

Completion Date:

June 2012

Related Keywords:

  • Liver Cancer
  • adult primary hepatocellular carcinoma
  • localized unresectable adult primary liver cancer
  • advanced adult primary liver cancer
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

Name

Location

University of Miami Sylvester Comprehensive Cancer Center - Miami Miami, Florida  33136