Efficacy and Safety of Sorafenib (Nexavar) in Combination With Gemcitabine in Advanced Hepatocellular Carcinoma (HCC)
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Purpose
This study is to evaluate the efficacy and safety of Sorafenib in combination with Gemcitabine in patients with advanced/unresectable HCC.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Hepatocellular |
Drug: Sorafenib and Gemcitabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter, Open Label, Single Arm, Phase II Study to Investigate the Efficacy and Safety of Sorafenib (Nexavar) in Combination With Gemcitabine in Patients With Advanced Hepatocellular Carcinoma (HCC) |
- To evaluate the efficacy (progression free survival (PFS)) of sorafenib in patients with advanced/unresectable HCC. [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
- To evaluate overall, survival, overall response rate (RECIST), time to progression (TTP), disease control rate (DCR) and side-effect profile of sorafenib in combination with gemcitabine in patients suffering from HCC. [ Time Frame: 2.5 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 45 |
| Study Start Date: | February 2008 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Sorafenib
|
Drug: Sorafenib and Gemcitabine
Sorafenib 400 mg po bid daily and Gemcitabine IV 1,000 mg/m2 on day 1,8, 15 of a 28-day cycle (up to 6 cycles), then followed by Sorafenib 400 mg po bid daily maintenance until disease progression.
Other Name: Nexavar and Gemzar
|
Detailed Description:
Hepatocellular carcinoma (HCC), also known as primary liver cancer, is the fifth most common cancer in the world. It is responsible for about 90 percent of the primary malignant liver tumors observed in adult and disproportionately affects men, with about three times as many men developing the disease as women.
Common symptoms in patients affected with HCC include abdominal pain, weight loss, weakness, fullness and anorexia, abdominal swelling, jaundice and vomiting.
Multiple clinical staging systems for hepatic tumors have been used such as the American Joint Committee on Cancer TNM system (stage 0, A, B, C, D) etc. However, the staging systems are still evolving with all attempts to improve the classification and prognosis prediction of HCC, and there is no agreement on the best staging that can be recommended world-wide.
For advanced HCC, sorafenib is likely to become the new standard of care. Combinational therapies with sorafenib have the potential to further improved therapeutic options for patients suffering from advanced HCC. Gemcitabine is a classical chemotherapeutic substance that has modest anti-cancer activity in HCC. However, its anti-cancer activity seems to be improved when combined with other anti-cancer drugs including drugs interfering with the VEGF pathway. Both substances, sorafenib and gemcitabine, have a favorable safety profile with a minimal overlap of side effects. Further the mode of actions of sorafenib and gemcitabine are likely to result in synergistic anti-tumor effects.
An open label, single arm, multicenter phase II study designed to determine progression free survival of patients with advanced stage HCC treated with sorafenib in combination with gemcitabine. Patients will receive up to 6 cycles of gemcitabine(IV 1000 mg/m2 on day 1, 8, 15 of a 28-day cycle) in combination with sorafenib (400 mg po bid daily) followed by sorafenib (400 mg po bid daily) maintenance until disease progression.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- patient at least 18 years of age with written informed consent prior to enrollment into the study.
- histologically or cytologically confirmed advanced unresectable and/or metastasis) HCC
- Child-Pugh class A or B
- Have measurable disease according to RECIST criteria
- life expectancy of at least 12 weeks, ECOG 0-2
- Have adequate bone marrow reserve and liver and renal function at screening
- Practice adequate contraception during study participation
Exclusion Criteria:
- Exclude medical conditions including history of cardiac disease, HIV infection,active infection,brain metastastasis or intracranial metastasis,seizure disorder requiring medication, history of organ allograft,evidence of or history of bleeding diathesis,previous or concurrent cancer with distinct in primary site or histology (with exception of cervical carcinoma in situ and treated basal cell carcinoma
- Excluded therapies and medications, previous and concomitant : prior systemic anticancer chemotherapy or immunotherapy or targeted therapy,hormonal therapy within 2 weeks,local treatment modality within 4 weeks,radiotherapy within 3 weeks,major surgery and unhealed wound within 4 weeks,autologous bone marrow transplant or stem cell rescue within 4 months
- other condition that may interfere with the patient's participation in the study or evaluation of the results
Contacts and Locations| Thailand | |
| Department of Medicine, Siriraj Hospital | |
| Bangkoknoi, Bangkok, Thailand, 10700 | |
| Medical Oncology Unit, Chulalongkorn Hospital | |
| Patumwan, Bangkok, Thailand, 10330 | |
| Horizon Regional Cancer Center, Bamrungrad Hospital | |
| Sukhumvit 3, Bangkok, Thailand, 10110 | |
| Principal Investigator: | Vichien Srimuninnimit, Assist.Prof. | Siriraj Hospital, Bangkok, Thailand |
More Information
Publications:
| Responsible Party: | Mahidol University |
| ClinicalTrials.gov Identifier: | NCT00703365 History of Changes |
| Other Study ID Numbers: | 12849 |
| Study First Received: | May 20, 2008 |
| Last Updated: | August 25, 2011 |
| Health Authority: | Thailand: Food and Drug Administration |
Keywords provided by Mahidol University:
|
Hepatocellular Carcinoma (HCC) |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Gemcitabine Sorafenib Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Protein Kinase Inhibitors |
ClinicalTrials.gov processed this record on May 21, 2013