Trial record 13 of 890 for:
Study of Sorafenib and Transarterial Chemoembolization (TACE) to Treat Hepatocellular Carcinoma
This study is ongoing, but not recruiting participants.
Biocompatibles UK Ltd
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
First received: February 4, 2009
Last updated: January 30, 2014
Last verified: January 2014
This study will combine two therapies to treat patients with unresectable hepatocellular carcinoma; sorafenib, and drug eluting beads delivered intra-arterially. The purpose of the study is to establish the safety and the effectiveness of the combination therapy. The investigators hypothesize that the combination of the two therapies will not result in greater toxicities to patients than that expected for either therapy given alone.
Procedure: LC Bead-TACE
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase II Trial of Sorafenib Combined With Doxorubicin Eluting Bead-Transarterial Chemoembolization (LC Bead-TACE) for Patients With Hepatocellular Carcinoma
Primary Outcome Measures:
- Safety will be assessed by grading toxicities reported at intervals throughout the study. Higher grade toxicities will be assessed for their degree of relatedness to the study treatment. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Efficacy will be assessed by review of the imaging scans, by comparing baseline scans to follow-up scan (post treatment). We will measure the size and viability of the treated lesions. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||July 2014 (Final data collection date for primary outcome measure)
Experimental: sorafenib and drug eluting beads
sorafenib: given 400 mg twice per day for as long as it is beneficial
Other Name: sorafenib (Nexavar)
Procedure: LC Bead-TACE
LC Beads loaded with doxorubicin
Doxorubicin loaded LC Beads: given intra-arterially into the liver, up to fours times in a 6 month period
Other Name: LC Beads manufactured by Biocompatibles
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Unresectable hepatocellular carcinoma patients with liver-predominant disease as described in section 5.1, or patients with hepatocellular carcinoma who refuse surgery. No more than 30% of the cohort should have macrovascular invasion and/or asymptomatic extrahepatic disease. Multifocal HCC is acceptable, no diffuse HCC.
- Age > 18 years old
- ECOG performance status of 0-1
- Childs class of A or B (up to 7) (see Table 5.0)
Adequate end-organ function as manifested by:
- Absolute neutrophil count of > 1500/mm3 and platelets > 50,000/mm3
- Creatinine ≤ 2.0
- AST ALT < 5 x ULN
- Total bilirubin of ≤ 3
- Albumin > 2.0
- INR < 2.0
- Leukocyte count >3000 cells/mm3
- Amylase and lipase ≤ 1.5 the upper limit of normal
- Patients who have received previous hepatic surgery , RFA, PEI, or cryoablation are eligible if target lesion(s) have not been treated and local therapy completed > 6 weeks prior to entry.
- Left ventricular ejection fraction ≥ 45%
- Patients with asymptomatic HIV infection are not eligible
- Willingness of male and female subjects, who are not surgically sterile or post menopausal, to use reliable methods of birth control for the duration of the study and for 30 days after the last dose of study medication.
- Patient must have signed informed consent prior to registration on study.
- Resolution of all acute toxic effects of any prior local treatment to CTC adverse event Grade 1 or 0.
- At least one tumor lesion can be accurately measured in at least one dimension according to RECIST. The lesion has not been previously treated with local therapy (such as surgery, radiation therapy, RFA, PEI, or cryoablation) unless it has shown progression in the interim.
- Patients unable to swallow oral medications
- Prior embolization, systemic or radiation therapy for HCC (liver)
- Tumor burden in the liver exceeding 70%.
- Complete occlusion of the entire portal venous system
- Ascites refractory to diuretic therapy (minimal or trace on imaging is acceptable)
- Previous or concurrent cancer that is distinct in primary site or histology from HCC, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis, and T1). Any cancer curatively treated > 3 years prior is permitted.
- Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
- History of bleeding within the past 4 weeks (unless deemed by PI as clinically insignificant, for ex., a brief episode of epistaxis)
- Any contraindication to doxorubicin administration
- Evidence of severe or uncontrolled systemic diseases,
- Congestive cardiac failure >NYHA class 2, MI within 6 months, active coronary artery disease, cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, unstable angina, or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial
- Any prior history of hypertensive crisis or hypertensive encephalopathy
- History of stroke or transient ischemic attack within 6 months prior to study enrollment
- Inadequately controlled hypertension (defined as systolic blood pressure of 150/100 mmHg on antihypertensive medications) (patients with treated hypertension are eligible)
- Significant vascular disease (e.g., aortic aneurysm, aortic dissection, peripheral vascular disease)
- History of organ allograft
- Presence of grade > 2 hepatic encephalopathy (see Appendix D)
- Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an additional experimental drug
- Evidence of bleeding diathesis or coagulopathy or on warfarin. Note: If a patient has been on coumadin for a period of 1 month and has been stable, they may be accepted into the protocol.
- Presence of clinically evident central nervous system or brain metastases
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1, anticipation of need for major surgical procedure during the course of the study
- Vascular anatomy that precludes catheter placement or injection of LC Bead microspheres
- Presence of collateral vessel pathways potentially endangering normal territories during embolization
- Pregnant (positive pregnancy test) or lactating
- Inability to comply with study and/or follow-up procedures
- Life expectancy of less than 12 weeks
- Child B8, B9 and C
- ECOG ≥ 2
- Patients with concomitant HIV infection or AIDS-related or serious acute or chronic illness
- Presence of porto-systemic shunt
- Severe atheromatosis
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of study results
- Active clinically serious infections (>grade 2)
- Patients receiving therapy for hepatitis A, B, or C.
- Patients with obvious and/or symptomatic extrahepatic disease. Findings of uncertain significance, such as lung lesions less than 10 mm in diameter or enlarged periportal lymph nodes will not exclude patients, however, findings highly suspicious for metastatic HCC will exclude patients from this study.
- Any contraindication for an arterial procedure such as impaired clotting tests (platelet count < 50.000/mm3 or prothrombin activity < 50 percent)
- Any contraindication for systemic chemotherapy administration (serum bilirubin > 3mg/dL, leukocyte count < 3.000 cells/mm3)
- Any contraindication for sorafenib administration
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00844883
|The Johns Hopkins Hospital
|Baltimore, Maryland, United States, 21287 |
Sidney Kimmel Comprehensive Cancer Center
Biocompatibles UK Ltd
No publications provided
||Sidney Kimmel Comprehensive Cancer Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 4, 2009
||January 30, 2014
||United States: Food and Drug Administration
Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
primary liver cancer
drug eluting beads
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 24, 2014
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Protein Kinase Inhibitors
Molecular Mechanisms of Pharmacological Action