Sorafenib With Capecitabine for Patients With Measurable Hepatocellular Carcinoma
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
Checked against the public recordLast updated Jun 2, 2021 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- New Mexico Cancer Research Alliance
- Interventions being studied
- Drug: Sorafenib & Capecitabine
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of New Mexico Cancer Center @ Lovelace Medical CenterAlbuquerque, New Mexico
- University of New Mexico Cancer CenterAlbuquerque, New Mexico
- Cancer Center at Presbyterian HospitalAlbuquerque, New Mexico
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 2, 2021. Always confirm current availability with the study team.