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

NCT01245582 | Withdrawn Phase 3 DMC

• 3 other identifiers: EFC11719U1111-1115-8557OXALI_R_05123
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Hepatic Neoplasm Malignant

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (2)

• Progression Free Survival (PFS)

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

• Response Rate (RR)

  From the date of randomization to the end of study.

Study Arms (2)

SECOX regimen

EXPERIMENTAL

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); Drug: capecitabine; Drug: sorafenib

Sorafenib alone

ACTIVE COMPARATOR

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

Drug: sorafenib

Interventions

oxaliplatin (SR96669) DRUG

Pharmaceutical form:injection Route of administration: intravenous

SECOX regimen

capecitabine DRUG

Pharmaceutical form:tablet Route of administration: oral

SECOX regimen

sorafenib DRUG

Pharmaceutical form:tablet Route of administration: oral

SECOX regimen; Sorafenib alone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Oxaliplatin; Capecitabine; Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Phenylurea Compounds; Urea; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Pyridines

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2010
• First Posted: November 22, 2010
• Study Start: July 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: August 1, 2015
• Last Updated: November 9, 2011

Record last verified: 2011-11