Oxaliplatin and Capecitabine on Top of Sorafenib Versus Sorafenib Alone in Advanced Hepatocellular Carcinoma Patients (SECOX)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01245582
First received: November 19, 2010
Last updated: November 8, 2011
Last verified: November 2011
  Purpose

Primary Objective:

- To evaluate the efficacy of SECOX regimen by adding oxaliplatin plus capecitabine to sorafenib versus sorafenib alone as palliative treatment for unresectable HCC patients to prolong overall survival (OS) for advanced HCC patients.

Secondary Objective:

  • To compare the efficacy of SECOX regimen with Sorafenib alone for progression free survival (PFS)
  • To compare the efficacy of SECOX regimen with Sorafenib alone for response rate (RR)
  • To assess the overall safety profile of SECOX regimen in comparison of Sorafenib alone

Condition Intervention Phase
Hepatic Neoplasm Malignant
Drug: oxaliplatin (SR96669)
Drug: capecitabine
Drug: sorafenib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase III Study of Oxaliplatin (Eloxatin) and Capecitabine on Top of Sorafenib Versus Sorafenib Alone as First-line Palliative Treatment in Advanced Hepatocellular Carcinoma Patients

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: From the date of randomization to the date of death due to any cause. ] [ Designated as safety issue: No ]
    defined as the time from randomization to the date of death due to any cause. If death is not observed at the cut off date, data on OS will be censored at the last date when patient is known to be alive or the cut-off date, whichever comes first.


Secondary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: From the date of randomization to the date of documentation of progression or death. ] [ Designated as safety issue: No ]
    defined as the time interval from the date of randomization to the date of first observation of disease progression or the date of death (due to any cause). If death or progression is not observed, data on PFS will be censored at the earlier date of last tumor assessment without evidence of progression and the cut-off date.

  • Response Rate (RR) [ Time Frame: From the date of randomization to the end of study. ] [ Designated as safety issue: No ]
    defined as the proportion of patients with confirmed complete response (CR) or confirmed partial response (PR), defined by RECIST 1.1 criteria


Enrollment: 0
Study Start Date: July 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SECOX regimen
Oxaliplatin (Eloxatin) 85mg/m2 , 2 hour infusion, day 1 Capecitabine (Xeloda) 850 mg/m2 BID orally daily, from day 1 to 7 Sorafenib (Nexavar) 400 mg BID orally daily, from day 1 to 14 (continuously)
Drug: oxaliplatin (SR96669)

Pharmaceutical form:injection

Route of administration: intravenous

Drug: capecitabine

Pharmaceutical form:tablet

Route of administration: oral

Drug: sorafenib

Pharmaceutical form:tablet

Route of administration: oral

Active Comparator: Sorafenib alone
Sorafenib (Nexavar) 400 mg BID orally daily, from day 1 to 14 (continuously)
Drug: sorafenib

Pharmaceutical form:tablet

Route of administration: oral


Detailed Description:

For each patient, the study consists of a baseline period of screening up to 2 weeks, a treatment period with 2 weeks as one study treatment cycle.

Each patient will be randomly assigned to receive either SECOX (Sorafenib, Oxaliplatin with Capecitabine) or Sorafenib alone every 2 weeks until disease progression, intolerable toxicity, or patient's refusal of further study treatment. There will be a 30-day follow-up visit after the last study treatment.

All patients will be follow-up every 2 months until death is observed during post-treatment follow-up period.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Subjects with histologically or cytologically or clinically diagnosed advanced HCC not amenable to surgical or local treatment. Documentation of original pathology for diagnosis is acceptable if tumor tissue is unavailable at screening.
  • Signed written informed consent

Exclusion criteria:

  • Clinically diagnosed subjects who did not meet two following criteria:

    • cirrhotic patients with focal lesion > 2cm with arterial hypervascularization demonstrated by 2 coincident imaging techniques
    • cirrhotic patients with focal lesion > 2cm with arterial hypervascularization demonstrated by 1 imaging technique and associated with Alpha Fetoprotein (AFP) level > 400 ng/mL
  • Subjects who are receiving or previously received any other investigational therapy or any other systemic anti-cancer treatment for HCC including chemotherapy, immunotherapy or targeted agents, except radiotherapy to non-target lesion (bone metastasis, etc) and HCC adjuvant therapy which was completed more than 6 months prior to randomization. Antiviral treatment is allowed, however interferon therapy must be stopped at least 4 weeks prior to randomization.
  • Subjects with main portal vein thrombosis.
  • Subjects with encephalopathy or history of encephalopathy, ascites uncontrolled by medication, active or history of variceal or gastrointestinal bleeding within 30 days
  • Subjects with Central Nervous System (CNS) metastasis
  • Subjects without one target tumor lesion that be measurable at baseline according to Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria
  • Subjects who have received local therapy such as surgery, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection within 4 weeks prior to randomization
  • Subjects with Child-Pugh > A
  • Eastern Cooperative Oncology Group (ECOG) > 2
  • Subjects with inadequate bone marrow, liver and renal function
  • Subjects with previous liver transplantation
  • Subjects with other serious diseases or medical conditions within 6 months that might be associated with a life expectancy of less than 3 months
  • Subjects with other malignant disease previously or concurrently, except cured basal cell carcinoma of skin, cervical carcinoma in situ or any cancer curatively treated > 3 years prior to study entry
  • Subjects with known severe hypersensitivity to sorafenib or any other component of sorafenib
  • Pregnant or lactating women, or women of child bearing potential without contraceptive method or unwilling to take effective contraception during the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01245582

Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01245582     History of Changes
Other Study ID Numbers: EFC11719, U1111-1115-8557, OXALI_R_05123
Study First Received: November 19, 2010
Last Updated: November 8, 2011
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Liver Neoplasms
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Adenocarcinoma
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 April 17, 2014