TerminatedPhase 2NCT01032850

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

StatusTerminated
PhasePhase 2
U.S. locations3
SponsorNew Mexico Cancer Research Alliance
01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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