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Clinical Study of Sorafenib and Zoledronic Acid to Treat Advanced HCC

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Fudan University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT01259193
First received: December 13, 2010
Last updated: April 13, 2011
Last verified: October 2010
  Purpose

Sorafenib ,an oral multikinase inhibitor targeting several tyrosine-kinase receptors with antiangiogenesis and antiproliferation of HCC, is the first approved target therapy for HCC.

Zoledronic acid is used for treatment of bone metastasis of diverse malignant cancer. Emerging data suggest that zoledronic acid may also exhibit anticancer properties.

The objectives of the study is to evaluate the safety of Sorafenib combined with Zoledronic Acid and to evaluate overall survival and time to progression.


Condition Intervention Phase
Hepatocellular Carcinoma
Drug: Sorafenib and Zoledronic Acid
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Sorafenib and Zoledronic Acid in Advanced HCC

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • numbers of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    to evaluate the toxicity of sorafenib in combination with zoledronic acid


Secondary Outcome Measures:
  • Overall survival (OS), time to progression (TTP) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    to evaluate the efficacy of sorafenib in combination with zoledronic acid


Estimated Enrollment: 50
Study Start Date: October 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sorafenib and Zoledronic Acid Drug: Sorafenib and Zoledronic Acid
Sorafenib ,tablet,400mg Bid ,until patient can not tolerance Zoledronic Acid ,powder for injection,4mg per 3 week for 1 year

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Hepatocellular carcinoma confirmed with pathology or identified with radiological images with typical features
  • patient with unresectable primary hepatocellular carcinoma
  • Child-Pugh Class A or B, score ≤ 7
  • ECOG score 0-2
  • Expected survival time not less than 12 weeks
  • At least one tumor nodule with one uni-dimension of ≥ 1 cm
  • Peripheral platelet of or more than 50×10(9)/L
  • Peripheral hemoglobin of or more than 85g/L
  • Peripheral albumen of or more than 28g/L
  • Total bilirubin ≤3.0mg/dl
  • ALT and AST ≤ 5.0 x the upper limit of normal
  • Serum amylase ≤ 1.5x the upper limit of normal
  • Serum creatinine ≤ 1.5x upper limit of normal
  • PT-INR<2.3 or PT prolong no more than 4s of normal

Exclusion Criteria:

  • Congestive heart failure > NYHA class 2
  • History of active coronary disease( except myocardial infarction more than 6 months ago)
  • Receive anti-arrhythmia treatment(except β-receptor blocker,calcium channel blocker and digoxin)
  • uncontrollable hypertension
  • Active clinically serious infections (> 2 NCI-CTC Version 3.0)
  • History of HIV infection
  • Inclined to hemorrhage or active hemorrhage with 1 month
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in this study
  • Pregnant or breast-feeding.Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to enrolling in this portion of the study
  • Known or suspected allergy to any agent given in association with this trial
  • Concomitant anti-cancer therapy (except immunotherapy and Chinese traditional treatment)
  • Surgical operation within 4 weeks prior to enrolling in this portion of the study
  Contacts and Locations
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: NCT01259193

Contacts
Contact: Zheng-Gang Ren, Ph.D 0086-021-64041990 ext 2149 ren.zhenggang@zs-hospital.sh.cn
Contact: Lan Zhang, Master 0086-021-64041990 ext 2171 zhang.lan@zs-hospital.sh.cn

Locations
China, Shanghai
Liver Cancer Institute Recruiting
Shanghai, Shanghai, China, 200032
Contact: Zheng-Gang Ren, Ph.D    0086-021-64041990 ext 2137    ren.zhenggang@zs-hospital.sh.cn   
Contact: Lan Zhang, Master    0086-021-64041990 ext 2171    zhang.lan@zs-hospital.sh.cn   
Principal Investigator: Zheng-Gang Ren, Ph.D         
Sub-Investigator: Jubo Zhang, PhD         
Sponsors and Collaborators
Fudan University
  More Information

Additional Information:
No publications provided

Responsible Party: Ren Zhenggang/Professor Sun Huichuan/Professor, Shanghai Zhongshan Hospital,China
ClinicalTrials.gov Identifier: NCT01259193     History of Changes
Other Study ID Numbers: SRFB-021, LCI-10-10-20
Study First Received: December 13, 2010
Last Updated: April 13, 2011
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
Hepatocellular Carcinoma
Sorafenib
Zoledronic Acid
toxic reaction

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Diphosphonates
Sorafenib
Zoledronic acid
Antineoplastic Agents
Bone Density Conservation Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014