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This study has been withdrawn prior to enrollment.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:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01245582
First received: November 19, 2010
Last updated: November 8, 2011
Last verified: November 2011
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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 Pharmaceutical form:tablet Route of administration: oral 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 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 June 17, 2013