Sorafenib Concurrent With Yttrium-90 Transarterial Radioembolization in Patients With Advanced Hepatocellular Cancer

NCT02288507 | Withdrawn Phase 1 DMC

• 1 other identifier: Acoba 2014 -1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the safety and efficacy of administering sorafenib concurrent with yttrium-90 radioembolization to patients with advanced hepatocellular cancer.

Conditions

Hepatocellular Cancer

Keywords

sorafenib, yttrium-90 radioembolization

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of concurrent sorafenib and yttrium-90 transarterial radioembolization (TARE) for patients with advanced hepatocellular cancer as measures by Adverse events

  All patients will be monitored and evaluated for clinical toxicities during the treatment period and queried at each follow-up visit for Adverse Events (AEs). Patients may volunteer information concerning AEs. All AEs will be graded by using the NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).

  2 months

Secondary Outcomes (1)

• Efficacy of concurrent sorafenib and yttrium-90 transarterial radioembolization (TARE) for patients with advanced hepatocellular cancer as measured by response rate, time to progression (TTP), progression free survival (PFS), overall survival (OS)

  1 year

Study Arms (1)

sorafenib & Yttrium-90 radioembolization

EXPERIMENTAL

Sorafenib dose de-escalation starting at 400mg PO BID starting on Day1 Yttrium-90 radioemoblization on Day 14

Drug: Sorafenib; Radiation: yttrium-90 radioembolization

Interventions

Sorafenib DRUG

Sorafenib 400mg PO BID for Cohort 1, if 2 or more patients with dose-limiting toxicity toxicity (DLT), Chort -1 is sorafenib 200mg PO BID, if 2 or more patients with DLT, sorafenib 200mg PO daily

Also known as: Nexavar, Bay 43-9006 tosylate, Bay 54-9085

sorafenib & Yttrium-90 radioembolization

yttrium-90 radioembolization RADIATION

Yttrium-90 SIR-Spheres microspheres are instilled through a catheter into a branch of the hepatic artery

Also known as: SIR-Spheres microspheres

sorafenib & Yttrium-90 radioembolization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed HCC or clinical diagnosis by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic subjects is required. m)
• Barcelona Clinic Liver Cancer Stage B or C. Segmental and subsegmental portal vein thrombosis is allowed.
• Metastatic disease is allowed if investigator feels liver directed therapy could offer palliative benefit (i.e., minimal extrahepatic tumor burden)
• No evidence of cirrhosis or cirrhosis grade of Child-Pugh class A or B7. Eligibility
• Have at least one tumor lesion that can be accurately measured according to Response Evaluation Criteria in Solid Tumor (RECIST v1.1).
• Consultation with interventional radiologist and deemed an appropriate candidate for TARE.
• Prior local therapy, such as surgery, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation is allowed if the index lesion(s) remains outside of the treatment field or has progressed since prior treatment. Local therapy must have been completed at least 4 weeks prior to the baseline scan.
• Prior yittrium-90 transarterial radioembolization (TARE) or sorafenib not allowed
• Patient must be informed of the investigational nature of this study, sign and give written informed consent in accordance with institutional and federal guidelines.
• Age ≥ 18 years.
• Eastern Cooperative Group (ECOG) performance status ≤ 1.
• Have adequate hematologic function as documented by an absolute neutrophil count (ANC) ≥ 1000/ul, platelet count ≥ 60,000/ul, and hemoglobin ≥ 8.5 mg/dl obtained within 28 days prior to registration.
• Have adequate hepatic function, as determined by the following tests measured within 28 days prior to registration: serum bilirubin ≤ 2 x upper limit of normal (ULN); serum glutamate oxaloacetate transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) ≤ 5 x the institutional upper limit of normal (IULN).
• Have adequate renal function, as determined by the following tests measured within 28 days prior to registration: serum creatinine ≤ 1.5 x ULN OR a measured creatinine clearance or calculated creatinine clearance ≥ 50 mL/min.
• Have a life expectancy of ≥12 weeks

You may not qualify if:

• Known or suspected allergy or hypersensitivity to sorafenib.
• Any malabsorption condition.
• Must not have known brain metastases.
• No concurrent anticancer chemotherapy or local therapy.
• No concurrent herbal or unconventional therapy (e.g., St. John's Wort)
• Pregnant or nursing women
• No prior radiation therapy to the liver
• Inability to perform y90 TARE due to: (1) inability to catheterize the hepatic artery, (2) portal vein thrombosis/occlusion without the ability to perform selective infusion, (3) Tecnetium-99m macro-aggregated albumin hepatic artery perfusion scintigraphy shows unfavorable shunt fraction between the liver and the pulmonary parenchyma as determined by the interventional radiologist, or (4) other contraindication to TARE identified by interventional radiologist.
• Women/men of reproductive potential unwilling or unable to use an effective contraceptive method
• No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 3 years.
• History of myocardial infarction, stroke, ventricular arrhythmia, or symptomatic conduction abnormality within 6 months.
• Concurrent severe or uncontrolled medical disease (i.e., active systemic infection, diabetes, coronary artery disease, congestive heart failure) that, in the opinion of the Investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study.

Sponsors & Collaborators

• University of Hawaii: lead

Study Sites (1)

University of Hawaii

Honolulu, Hawaii, 96813, United States

Location

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Jared Acoba, MD

  University of Hawaii

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 5, 2014
• First Posted: November 11, 2014
• Study Start: November 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: November 8, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)