Effectiveness and Safety Study of TACE Plus Oral Sorafenib for Unresectable HCC

NCT00576056 | Terminated Phase 2 Results DMC

• 1 other identifier: 07-047
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if TACE plus Sorafenib will improve outcome in patients with advanced hepatocellular carcinoma (HCC) not amenable to surgery.

Conditions

Carcinoma, Hepatocellular

Keywords

Hepatocellular; Carcinoma; TACE; Sorafenib; Transcatheter Arterial Chemoembolization; Nexavar; Unresectable

Outcome Measures

Primary Outcomes (1)

• Determine Progression-free Survival in This Patient Population Treated With the Proposed Combination Treatment Modality

  Progression free survival (PFS) is calculated as the time interval between the date on which a patient first received protocol treatment and the documented date of disease progression or death. For a surviving and progression-free patient, PFS is censored by the last follow-up date when that patient is documented to be progression free. Progression is defined using RECIST v1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions.

  Up to 24 months (from initial treatment through 12 months follow-up)

Secondary Outcomes (1)

• Determine the Overall Survival in Patients Treated With This Combination Regimen

  From date of initial treatment until the date of death from any cause

Study Arms (1)

Tace and Sorafenib

EXPERIMENTAL

Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment.

Drug: Sorafenib; Drug: TACE

Interventions

Sorafenib DRUG

Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination.

Also known as: Nexavar

Tace and Sorafenib

TACE DRUG

TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin.

Also known as: Transarterial Chemoembolization

Tace and Sorafenib

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with HCC seen at UPMC will be enrolled in this study if they meet the following eligibility criteria:
• Adults patients (≥ 18 years of age) with a diagnosis of HCC which is not amenable to surgical resection or local ablative therapy
• Histological confirmed HCC or clinical/laboratory diagnosis of HCC or nodules larger than 2 cm with typical vascular features or AFP \> 200
• Patient must have quantifiable disease limited to the liver
• Patients must have at least one tumor lesion that meets both of the following criteria:
• The lesion can be accurately measured in at least one dimension according to RECIST criteria
• The lesion has not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
• ECOG performance status (PS) \<2
• No prior targeted antiangiogenic therapy. Metronomic chemotherapies are allowed. At least 4 weeks since prior systemic chemotherapy
• At least 4 weeks since prior TACE
• At least 4 weeks since prior interferon
• Not pregnant
• No significant baseline liver dysfunction. Cirrhotic status of Child-Pugh class A only
• No significant renal impairment (creatinine clearance \< 30 mL/minute) or patients on dialysis
• No current infections requiring antibiotic therapy

You may not qualify if:

• Previous or concurrent cancer that is distinct in primary site or histology from HCC except cervical carcinoma in situ, treated basal-cell carcinoma of the skin, superficial bladder tumors (Ta, Tis \& T1), and any cancer curatively treated \> 3 years prior to entry is permitted
• Renal failure requiring hemo- or peritoneal dialysis
• Child-Pugh B \& C hepatic impairment
• History of cardiac disease: \> NY Heart Association (NYHA) class 2 congestive heart failure, active coronary artery disease, cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, and uncontrolled hypertension. Myocardial infarction more than 6 months prior to study entry is permitted.
• Active clinically serious infections (\> CTCAEv3 grade 2)
• Known history of HIV
• Known central nervous system tumors including metastatic brain disease
• History of organ allograft
• Substance abuse (current), psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
• Known or suspected allergy to the investigational agents or any agent given in association with this trial.
• Patients unable to swallow oral medications.
• Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of the study drug. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.
• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
• Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 90 mmHg, despite optimal medical management
• Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months

Sponsors & Collaborators

• University of Pittsburgh: lead
• Bayer: collaborator

Study Sites (1)

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Carcinoma

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; 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

Results Point of Contact

• Title: Dr. David Geller
• Organization: University of Pittsburgh Medical Center

gellerda@upmc.edu

412-692-2001

Study Officials

• Thomas C Gamblin, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN BA

Study Record Dates

• First Submitted: December 14, 2007
• First Posted: December 18, 2007
• Study Start: January 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: April 1, 2010
• Last Updated: February 15, 2017
• Results First Posted: December 28, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)