Study Stopped
Low accrual rate
Sorafenib With Capecitabine for Patients With Measurable Hepatocellular Carcinoma
Sorafenib in Combination With Capecitabine for Patients With Measurable Hepatocellular Carcinoma
2 other identifiers
interventional
15
1 country
3
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 hepatocellular-carcinoma
Started Sep 2009
Longer than P75 for phase_2 hepatocellular-carcinoma
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 14, 2009
CompletedFirst Posted
Study publicly available on registry
December 16, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedResults Posted
Study results publicly available
July 17, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedJune 2, 2021
June 1, 2016
2.7 years
December 14, 2009
June 6, 2015
May 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Experiencing Adverse Events
The primary objective of the study is to evaluate safety and tolerability of the study treatment regimen. The analyses will be descriptive and no formal hypotheses testing will be performed. Toxicities (i.e. Adverse Events) are evaluated prior to each treatment and during any clinical visit.
6 months
Secondary Outcomes (3)
Disease Control Rate of Response (DCR)
6 months
Overall Survival (OS)
5 years
Progression Free Survival (PFS)
5 years
Study Arms (1)
Arm 1: Sorafenib & Capecitabine
EXPERIMENTALIntervention: Sorafenib \& Capecitabine: Sorafenib twice a day by mouth (400mg) Capecitabine twice a day by mouth (850mg)
Interventions
Intervention: Sorafenib twice a day by mouth (400mg), Capecitabine twice a day by mouth (850mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days.
Eligibility Criteria
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.
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- New Mexico Cancer Research Alliancelead
- Bayercollaborator
Study Sites (3)
University of New Mexico Cancer Center @ Lovelace Medical Center
Albuquerque, New Mexico, 87102, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
Cancer Center at Presbyterian Hospital
Albuquerque, New Mexico, 87110, United States
Related Publications (1)
Patt Y, Rojas-Hernandez C, Fekrazad HM, Bansal P, Lee FC. Phase II Trial of Sorafenib in Combination with Capecitabine in Patients with Hepatocellular Carcinoma: INST 08-20. Oncologist. 2017 Oct;22(10):1158-e116. doi: 10.1634/theoncologist.2017-0168. Epub 2017 Jul 7.
PMID: 28687627DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Yehuda Patt, MD
- Organization
- University of New Mexico Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Yehuda Z. Patt, MD
University of New Mexico Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2009
First Posted
December 16, 2009
Study Start
September 1, 2009
Primary Completion
May 1, 2012
Study Completion
August 1, 2017
Last Updated
June 2, 2021
Results First Posted
July 17, 2015
Record last verified: 2016-06