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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This study has been withdrawn prior to enrollment.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

November 19, 2010
November 8, 2011
July 2011
February 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01245582 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Oxaliplatin and Capecitabine on Top of Sorafenib Versus Sorafenib Alone in Advanced Hepatocellular Carcinoma Patients
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

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatic Neoplasm Malignant
  • 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

  • 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)
    Interventions:
    • Drug: oxaliplatin (SR96669)
    • Drug: capecitabine
    • Drug: sorafenib
  • Active Comparator: Sorafenib alone
    Sorafenib (Nexavar) 400 mg BID orally daily, from day 1 to 14 (continuously)
    Intervention: Drug: sorafenib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
August 2015
February 2014   (final data collection date for primary outcome measure)

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.

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01245582
EFC11719, U1111-1115-8557, OXALI_R_05123
Yes
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP