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

NCT ID: NCT01245582

Last Updated: 2011-11-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2015-08-31

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.

Conditions

Hepatic Neoplasm Malignant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

oxaliplatin (SR96669)

Intervention Type: DRUG

Pharmaceutical form:injection

Route of administration: intravenous

capecitabine

Intervention Type: DRUG

Pharmaceutical form:tablet

Route of administration: oral

sorafenib

Intervention Type: DRUG

Pharmaceutical form:tablet

Route of administration: oral

Sorafenib alone

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

Group Type: ACTIVE_COMPARATOR

sorafenib

Intervention Type: DRUG

Pharmaceutical form:tablet

Route of administration: oral

Interventions

oxaliplatin (SR96669)

Pharmaceutical form:injection

Route of administration: intravenous

Intervention Type: DRUG

capecitabine

Pharmaceutical form:tablet

Route of administration: oral

Intervention Type: DRUG

sorafenib

Pharmaceutical form:tablet

Route of administration: oral

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Other Identifiers

U1111-1115-8557

Identifier Type: OTHER

Identifier Source: secondary_id

OXALI_R_05123

Identifier Type: OTHER

Identifier Source: secondary_id

EFC11719

Identifier Type: -

Identifier Source: org_study_id