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

Primary Purpose

Hepatic Neoplasm Malignant

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

oxaliplatin (SR96669)

capecitabine

sorafenib

About this trial

This is an interventional treatment trial for Hepatic Neoplasm Malignant

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SECOX regimen

Sorafenib alone

Arm Description

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)

Sorafenib (Nexavar) 400 mg BID orally daily, from day 1 to 14 (continuously)

Outcomes

Primary Outcome Measures

Overall Survival (OS)

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)

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)

defined as the proportion of patients with confirmed complete response (CR) or confirmed partial response (PR), defined by RECIST 1.1 criteria

Full Information

NCT ID

NCT01245582

First Posted

November 19, 2010

Last Updated

November 8, 2011

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT01245582

Brief Title

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

Acronym

SECOX

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Withdrawn

Study Start Date

July 2011 (undefined)

Primary Completion Date

February 2014 (Anticipated)

Study Completion Date

August 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatic Neoplasm Malignant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SECOX regimen

Arm Type

Experimental

Arm Description

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)

Arm Title

Sorafenib alone

Arm Type

Active Comparator

Arm Description

Sorafenib (Nexavar) 400 mg BID orally daily, from day 1 to 14 (continuously)

Intervention Type

Drug

Intervention Name(s)

oxaliplatin (SR96669)

Intervention Description

Pharmaceutical form:injection Route of administration: intravenous

Intervention Type

Drug

Intervention Name(s)

capecitabine

Intervention Description

Pharmaceutical form:tablet Route of administration: oral

Intervention Type

Drug

Intervention Name(s)

sorafenib

Intervention Description

Pharmaceutical form:tablet Route of administration: oral

Primary Outcome Measure Information:

Title

Overall Survival (OS)

Description

Time Frame

From the date of randomization to the date of death due to any cause.

Secondary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

Time Frame

From the date of randomization to the date of documentation of progression or death.

Title

Response Rate (RR)

Description

defined as the proportion of patients with confirmed complete response (CR) or confirmed partial response (PR), defined by RECIST 1.1 criteria

Time Frame

From the date of randomization to the end of study.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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