Study of Sorafenib, Gemcitabine, and Cisplatin in Advanced Hepatocellular Carcinoma (HCC)

NCT00808145 | Withdrawn Phase 2

• 1 other identifier: 2008-108
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will look at the safety and efficacy of treating advanced hepatocellular carcinoma in patients who have not yet received systemic chemotherapy. Previous local treatment of hepatic lesions is permitted The treatment will use a combination of three FDA approved chemotherapy drugs, Gemcitabine, Cisplatin and Sorafenib. Sorafenib is FDA approved for the treatment of hepatocellular cancer, gemcitabine and cisplatin are not approved for the treatment of hepatocellular cancer.

Conditions

Hepatocellular Carcinoma

Keywords

Treatment of advanced liver cancer

Outcome Measures

Primary Outcomes (1)

• Safety of the combination of gemcitabine/cisplatin/sorafenib

  one year

Secondary Outcomes (1)

• Effectiveness of gemcitabine/cisplatin/sorafenib in shrinking tumors extending time to progression of disease

  6 months

Study Arms (1)

Gemcitabine/Cisiplatin/Sorafenib

EXPERIMENTAL

All eligible patients will receive intravenous gemcitabine/cisplatin + daily oral sorafenib until disease progression occurs

Drug: Gemcitabine / Cisplatin / Sorafenib

Interventions

Gemcitabine / Cisplatin / Sorafenib DRUG

All patients will receive gemcitabine 1000mg/m2 cisplatin 30mg/m2 sorafenib 400mg orally twice daily

Also known as: nexavar - sorafenib, gemzar - gemcitabine, cisplatin

Gemcitabine/Cisiplatin/Sorafenib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hepatocellular carcinoma: diagnosed histologically, cytologically, or clinically by a rising AFP \> 500 ng/ml in the setting of cirrhosis and a radiographically compatible lesion.
• No prior systemic therapy; local therapy such as chemoembolization, radiofrequency ablation or cryoablation is allowed.
• Measurable disease \> 1 cm by CT or MRI. Lesions which have received local therapy do not qualify as measurable target lesions.
• Age \> 18 years old
• ECOG Performance Status 0 or 1
• Child-Pugh status A and B
• Adequate bone marrow, liver and renal function as assessed by the following:
• Hemoglobin ≥ 9.0 g/dl
• Absolute neutrophil count (ANC) ≥ 1,250/mm3
• Platelet count ≥ 80,000/mm3
• Total bilirubin ≤ 3.0 mg/dl
• ALT and AST ≤ 5 times the ULN
• Amylase and lipase ≤ 1.5 times ULN
• Creatinine ≤ 1.5 times ULN
• Resolution of all acute toxic effects of any prior local treatment to CTC Adverse Events grade £1.

You may not qualify if:

• Prior surgery, radiation or local therapy within 4 weeks.
• Prior treatment with either sorafenib, gemcitabine, or cisplatin
• Cardiac disease: Congestive heart failure \> class II NYHA. Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
• Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
• Uncontrolled hypertension defined as sustained systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management.
• Known human immunodeficiency virus (HIV) infection
• Active clinically serious infection \> CTCAE Grade 2.
• Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
• Serious non-healing wound, ulcer, or bone fracture.
• Evidence or history of bleeding diathesis or coagulopathy
• Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
• Use of St. John's Wort or rifampin (rifampicin).
• Known or suspected allergy to sorafenib, cisplatin, or gemcitabine.
• Any condition that impairs patient's ability to swallow whole pills.

Sponsors & Collaborators

• Lahey Clinic: lead

Study Sites (1)

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Gemcitabine; Cisplatin; 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)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Pyridines

Study Officials

• Keith E. Stuart, M.D.

  Lahey Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2008
• First Posted: December 15, 2008
• Study Start: February 1, 2009
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 22, 2014

Record last verified: 2014-10

Locations

US (1)