Sorafenib With Capecitabine for Patients With Measurable Hepatocellular Carcinoma

Stopped early · Phase 2

Conditions studied: Hepatocellular Carcinoma

In brief

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

Key facts

Study ID

NCT01032850

Run by

New Mexico Cancer Research Alliance

People needed

15

Starts

2009-09-01

Expected to finish

2017-08-01

Last updated by the study team

2021-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of New Mexico Cancer Center @ Lovelace Medical Center — Albuquerque, New Mexico, United States
• University of New Mexico Cancer Center — Albuquerque, New Mexico, United States
• Cancer Center at Presbyterian Hospital — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

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