Sorafenib With Capecitabine for Patients With Measurable Hepatocellular Carcinoma

• Status: Terminated
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This research study will evaluate Sorafenib (Nexavar®) and Capecitabine (Xeloda®) to see the following:

• how effective this combination of study drugs will be in treating HCC

• how long subjects respond to these study drugs

• what types of side effects can be expected, and

• how severe the side effects are

All subjects in this study will receive:

• Sorafenib twice a day by mouth

• Capecitabine twice a day by mouth

Treatment will be given in a 28-day treatment cycle.

Subjects will take sorafenib every day of the cycle. Subjects will take capecitabine on days 1-7 and 15-21 of the cycle

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New Mexico Cancer Care Alliance
• Collaborator: Bayer
• Treatments: Capecitabine; Niacinamide; Sorafenib

Criteria

Inclusion Criteria:

Histologic diagnosis of hepatocellular carcinoma The lesion or lesions are not resectable with curative intent. Prior loco-regional treatment (resection, RFA, chemoembolization) is allowed.

Adequate bone marrow function:

• Absolute neutrophil count (AGC) >1500/µL

• Platelet count >60,000 /µL

Renal function:

• Serum creatinine < 2.0 mg/dl, and a calculated CCT of > 30 mL/min. Hepatic function:(Patients with a Child-Pugh (C-P) class A-B)

• Bilirubin < 2.8 mg/dl (provided the Child-Pugh class of liver cirrhosis is A or B (7) (ie. The Child-Pugh score is only 7 points)

• ALT and AST ≤ 5.0 times the ULN • Hemoglobin > 8.5 g/dl

ECOG/Zubrod/SWOG Performance Status = 0>1 Life expectancy > 16 weeks Male or female' age >18 years Patients of childbearing potential must be using an effective means of contraception.

INR < 1.5 or a PT/PTT within normal limits.

Exclusion Criteria:

• Any prior systemic therapy including chemotherapy of targeted agents

• Uncontrolled ascites defined as not easily controlled by stable doses of diuretics.

• Pregnant or lactating females

• Cardiac disease: Congestive heart failure > class II NYHA. Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.

• Uncontrolled' clinically significant dysrhythmia

• History of prior malignancy within the prior 3 years, with the exception of non-melanoma carcinomas of the skin, carcinoma in situ of the cervix or breast, Rai Stage I chronic lymphocytic leukemia and superficial bladder cancer.

• Prior radiotherapy to an indicator lesion unless there is objective evidence of tumor growth in that lesion

• Uncontrolled metastatic disease of the central nervous system

• Radiotherapy within the 2 weeks before Cycle 1' Day 1

• Surgery within the 2 weeks before Cycle 1' Day 1

• Any co morbid condition that' in the view of the attending physician' renders the patient at high risk from treatment complications.

• Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.

• Known human immunodeficiency virus (HIV) infection.

• Patients with chronic Hepatitis B or C infections are eligible.

• Active clinically serious infection > CTCAE Grade 2.

• Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.

• Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug.

• Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug.

• Serious non-healing wound, ulcer, or bone fracture.

• Evidence or history of bleeding diathesis or coagulopathy.

• Use of St. John's Wort or rifampin (rifampicin).

• 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.

• Any malabsorption problem.