Study of Sorafenib With Combination of Thalidomide in Hepatocellular Carcinoma (HCC)

NCT00971126 | Terminated Phase 1 DMC

• 1 other identifier: TCOGP-1209
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this phase I study is to determine the maximal tolerable dose (MTD) of thalidomide (THADO®) in combination with fixed dose of sorafenib (NEXAVAR®) for the treatment of advanced or metastatic HCC. The Phase II purpose of this study is to determine the disease control rate (complete response + partial response + stable disease) for at least 4 months of sorafenib (NEXAVAR®) plus phase I determined MTD of thalidomide (THADO®) in patients with advanced or metastatic HCC.

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• Terms of efficacy assessment: objective tumor response, overall survival, progression-free survival. Terms of safety assessment: adverse effects, laboratory values.

  The overall survival will be measured from the time the patient has started protocol treatment to the date of the patient's death. 2. An interim analysis of safety profiles will be reviewed by safety committee.

Study Arms (1)

Single Group Assignment

EXPERIMENTAL

Drug: sorafenib (Nexavar®), thalidomide (Thado®)

Interventions

sorafenib (Nexavar®), thalidomide (Thado®) DRUG

Phase I Fixed dose of Sorafenib 800mg/day (400mg, p.o., bid); and Escalation dose of Thalidomide at dose Level I: 50 mg/day (50mg, p.o., qd); Level II: 100 mg/day (50mg, p.o., bid); Level III: 150 mg/day (100mg/50mg, p.o., bid); Level IV: 200 mg/day (100mg, p.o., bid). Phase II Fixed dose of Sorafenib 800mg/day (400mg, p.o., bid); and MTD of Thalidomide at phase I study.

Also known as: Nexavar®), Thado®

Single Group Assignment

Eligibility Criteria

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

You may qualify if:

• Patients must be at least 18 years of age.
• With histologically or cytologically documented HCC or clinically diagnosed HCC.
• Advanced (surgically unresectable and unsuitable for local therapy), and/or metastatic HCC, and/or patient refused local therapy.
• Performance status of ECOG score 0-2.
• Life expectancy of at least 12 weeks.
• At least one tumor lesion that meets both of the following criteria:
• measurable (must be by CT-scan or MRI) in at least one dimension according to RECIST;
• the lesion has not been previously treated with local therapy, such as radiation therapy, hepatic arterial (chemo) embolization, radiofrequency ablation, and percutaneous interventional therapy.
• Previous local therapy, such as radiotherapy, hepatic arterial (chemo)embolization, radiofrequency ablation, percutaneous interventional therapy, is allowed but the treatment must be completed at least 4 weeks prior to the baseline scan.
• Patients have adequate bone marrow reserves defined as:
• ANC ≧ 1,500/μl;
• Platelets count ≧ 75,000/μl;
• Hemoglobin ≧ 8.5 g/dl.
• Adequate liver and renal functions defined as:
• Child-Turcotte-Pugh score of 7 or lower (class A and well-compensated class B);

You may not qualify if:

• Previous use of systemic anti-cancer therapy for HCC such as chemotherapy, immunotherapy, and targeting therapy within 4 weeks to study entry.
• Patients with prior use of investigational drugs including sorafenib and thalidomide.
• Active cardiac disease, including CHF NYHA class \> 2, active CAD, cardiac arrhythmias requiring anti-arrhythmic therapy other than beta-blockers or digoxin, and uncontrolled hypertension.
• Patients with hemorrhagic diathesis or have history of active bleeding with 30 days prior to study entry.
• History of HIV infection.
• Active or uncontrolled infections requiring antibiotics treatment.
• Metastatic brain or leptomeningeal tumours unless the patients is \> 6 months from definitive therapy, has negative imaging study within 4 weeks of study entry, and is clinically stable with respect to the tumour at the time of study entry.
• With seizure disorder requiring medication (such as steroids or anti-epileptics).
• History of organ allograft.
• Undergoing renal dialysis.
• Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bluffer tumours \[Ta, Tis \& T1\] or any cancer curatively treated \> 3 years prior to study entry.
• Pregnant or breast-feeding patients.

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead
• National Cheng-Kung University Hospital: collaborator
• Chang Gung Memorial Hospital: collaborator

Study Sites (1)

Ghang-Gung Memorial Hospital at Chia-Yi

Chiayi City, 613, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib; Thalidomide

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; 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; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Chung Hu Chan, MD, PHD

  National Health Research Institutes, Taiwan

  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: SPONSOR

Study Record Dates

• First Submitted: July 1, 2009
• First Posted: September 3, 2009
• Study Start: July 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: March 1, 2010
• Last Updated: May 4, 2016

Record last verified: 2009-09

Locations

TW (1)