Text Size

Sorafenib With Capecitabine and Oxaliplatin for Advanced or Metastatic Hepatocellular Carcinoma (SECOX)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by The University of Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00752063
First received: September 1, 2008
Last updated: September 12, 2008
Last verified: September 2008
History of Changes
  Purpose

HCC is an aggressive, largely chemo-resistant cancer with a poor prognosis, currently there is no effective systemic chemotherapy for HCC. Epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF) are both overexpressed in HCC and thought to contribute to tumor development. Oxaliplatin in combination with other chemotherapies or biologic agents have been shown to be an effective and safe treatment in advanced HCC patients.

Sorafenib, an oral multi-kinase inhibitor, blocks tumor cell proliferation by targeting multiple growth factor pathways and also exerts an anti-angiogenic effect. Clinically, single agent Sorafenib has been shown to have some efficacy in patients with advanced HCC and the primary result of prolonged overall survival seems to have been achieved in the phase III trial.


Condition Intervention Phase
Advanced Hepatocellular Carcinoma
Metastatic Hepatocellular Carcinoma
 Drug: Sorafenib with Capecitabine and Oxaliplatin
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase IIa Trial of Sorafenib With Capecitabine and Oxaliplatin in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 4 cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumor response rate, overall survival and safety of the regimen in HCC patients [ Time Frame: 8 cycles ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 52
Study Start Date: September 2007
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
All subjects will receive Sorafenib with Capecitabine and Oxaliplatin
 Drug: Sorafenib with Capecitabine and Oxaliplatin
Regimen 1: Oxaliplatin 85 mg/m2 (50 mg per vial) administered intravenously on day 1 of each cycle Regimen 2: Capecitabine 1700 mg/m2 p.o. (850 mg/m2 BD) day 1 to 7 Regimen 3: Sorafenib 400 mg (200 mg/tablet) orally BD day 1 to 14

Detailed Description:

Hepatocellular carcinoma (HCC) is the most common primary liver malignancy, with an annual incidence of over 500,000 new patients and more than half of the new cases occur in China. The most common etiological causes of HCC are hepatitis B and hepatitis C viral infections.

HCC is a cancer of high particular relevance in Hong Kong because of the high prevalence (10%) of hepatitis B virus infection in the population. It is the second most common cancer causing death in Hong Kong. Surgical resection and liver transplantation are regarded as the main curative treatments for HCC. Nevertheless, the majority of patients have unresectable HCCs because of advanced tumor stage and poor liver function. Besides, transplantation is indicated only for early small HCCs, and its application is limited by the shortage of liver graft, which is a particularly severe problem in Hong Kong.

HCC is an aggressive, largely chemo-resistant cancer with a poor prognosis, currently there is no effective systemic chemotherapy for HCC. Epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF) are both overexpressed in HCC and thought to contribute to tumor development. Oxaliplatin in combination with other chemotherapies or biologic agents have been shown to be an effective and safe treatment in advanced HCC patients. Sorafenib, an oral multi-kinase inhibitor, blocks tumor cell proliferation by targeting multiple growth factor pathways and also exerts an anti-angiogenic effect.

Sorafenib has been approved by FDA for use in renal cell carcinoma based on prolonged survival in phase III trials. Single agent Sorafenib has been shown to have some efficacy in patients with advanced HCC and the primary result of prolonged overall survival have been achieved in a recent randomized phase III trial. However, most patients would only have disease stabilization as the phase II trial only showed a tumor response rate of only 8% (PR & MR). Combination with chemotherapy may improve the tumor response rate.

  Eligibility

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

Inclusion Criteria:

  • Patients with locally advanced or metastatic HCC not suitable surgical or locoregional therapies
  • Age more than 18 years
  • Performance status 0 or 1
  • Life expectancy of 3 months
  • Prior radiotherapy more than 3 weeks prior to study entry
  • No prior systemic therapy
  • Hb more than 8.5 g/dl
  • ANC more than 1,500/mm3
  • PLT more than 75 x 109/L
  • PT-INR/PTT less than 1.5 x upper limit of normal
  • Total bilirubin of less than 1.5 x upper limit of normal
  • Serum creatinine less than 1.5 x upper limit of normal
  • Serum AST and ALT less than 2.5 x upper limit of normal

Exclusion Criteria:

  • History of cardiac disease
  • Symptomatic metastatic brain or meningeal tumors
  • Main portal vein tumor thrombosis
  • Ascites uncontrolled by medication
  • Variceal or gastrointestinal bleeding within three months prior to start of treatment
  • Seizure disorder requiring medication
  • Patients undergoing renal dialysis
  • Previous or concurrent cancer that is distinct in primary site
  • Prior use of any systemic anti-cancer treatment
  • Prior use of Raf-kinase inhibitors (RKI), VEGF inhibitors, MEK inhibitors or Farnesyl transferase inhibitors
  • Patients on any local ablative treatment or TACE within 6 weeks
  • Radiotherapy during study or within 3 weeks
  • Major surgery within 4 weeks
  • Concomitant treatment of rifampin or St John's Wort
  • Pregnant or breast-feeding patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00752063

Locations
China
Queen Mary Hospital Recruiting
Hong Kong, China
Contact: Ida Choi, MPhil     (852)28553635     cychoia@hkucc.hku.hk    
Principal Investigator: Ronnie Poon, MD            
Sponsors and Collaborators
The University of Hong Kong
  More Information

No publications provided

Responsible Party: Professor Ronnie Poon, The University of Hong Kong,
ClinicalTrials.gov Identifier: NCT00752063     History of Changes
Other Study ID Numbers: HKU-SRG-P001
Study First Received: September 1, 2008
Last Updated: September 12, 2008
Health Authority: Hong Kong: Department of Health

Keywords provided by The University of Hong Kong:
Sorafenib
Capecitabine
Oxaliplatin
Advanced Hepatocellular Carcinoma
Metastatic Hepatocellular Carcinoma

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Oxaliplatin
Capecitabine
 Sorafenib
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013