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TerminatedPhase 2NCT01032850
Official study title

Sorafenib With Capecitabine for Patients With Measurable Hepatocellular Carcinoma

Study 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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedSorafenib & Capecitabine

The study team can explain what participation involves.

Who it may be forHepatocellular Carcinoma

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 2, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?New Mexico Cancer Research Alliance

Study sponsor

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

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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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