Clinical trial NCT01334112: Study of Axitinib in Patients With Unresectable Hepatocellular Carcinoma
Official title: A Phase II Trial of Axitinib (AG-013736) After Prior Antiangiogenic Therapy in Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
Advanced Hepatocellular Carcinoma
Liver Cancer
Axitinib
AG-013736
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2011-04-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the potential role of Axitinib (AG-013736) in the treatment of unresectable/metastatic hepatocellular carcinoma (HCC)

Detailed description: This is a phase II study of an investigational drug, Axitinib following prior antiangiogenic therapy in patients with advanced hepatocellular carcinoma. Hepatocellular carcinoma (HCC) is a primary cancer of the liver. Angiogenesis is a physiological process involving the growth of new blood vessels from pre-existing vessels. A tyrosine kinase is an enzyme that can inhibit angiogenesis. In this study, patients with advanced HCC who have failed prior antiangiogenic therapy, will receive Axitinib in cycles of 4 weeks. Axitinib is an oral, potent and selective inhibitor of angiogenesis. This study will evaluate the response rate of HCC following treatment with Axitinib as well as safety, feasibility, overall survival of patients, progression-free survival, and quality of life in persons with unresectable HCC. The study also compares response determined by RECIST to response determined by Choi Criteria.

Eligibility criteria: Inclusion Criteria:

* Unresectable and/or metastatic Hepatocellular Carcinoma
* Previous treatment with tyrosine kinase inhibitors or antiangiogenic drugs
* Life expectancy of ≥12 weeks
* At least one tumor lesion
* At least 2 weeks since the end of prior systemic treatment
* No evidence of pre-existing uncontrolled hypertension
* ECOG 0 or 1
* Adequate organ function
* Not appropriate for curative therapy
* Child A or B7 cirrhosis
* CLIP score ≤ 4

Exclusion Criteria:

* Received any other systemic therapy for Hepatocellular Carcinoma within 2 weeks prior to treatment
* Major surgery \<4 weeks or radiation therapy \<2 weeks of starting the study treatment
* Previous or concurrent cancer that is distinct in primary site or histology from Hepatocellular Carcinoma
* Severe acute or chronic medical or psychiatric condition
* Need for treatment with prohibited drugs
* Has received local therapy to all measurable lesions
* Stage B8 or higher liver cirrhosis
* Ascites refractory to diuretic therapy
* Clinically significant ECG abnormality

Primary outcomes:
measure: Response rate
timeFrame: Response rate assessed by CT scan at 16 weeks
Secondary outcomes:
measure: Feasibility
timeFrame: Assessed at the end of stage 1 (10 patients accrued) and at the end of trial (Stage 2, 29 patients total)
measure: Overall survival
timeFrame: At the completion of trial, 1.5 years
measure: Response rate comparison
timeFrame: Comparison of outcomes with RECIST criteria to Choi criteria and changes to perfusion on DCE ultrasound will occur at the end of stage 1 (after accrual of 10 patients) and trial completion
measure: Progression-free survival
timeFrame: At trial completion, 1.5 years
measure: Quality of life
timeFrame: At completion of trial, 1.5 years
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: At completion of trial, 1.5 years
measure: Number of Participants with Adverse Events as a Measure of Safety
timeFrame: At completion of trial, 1.5 years
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Hospital, Alberta Health Services
state: Alberta
city: Toronto
country: Canada
facility: University Health Network, Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Princess Margaret Hospital
name: Jennifer Knox, MSc, FRCPC, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Kelly Burak, MD, FRCPC, BSc, MSc
role: PRINCIPAL_INVESTIGATOR
References: