Cisplatin or Carboplatin and Sorafenib in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery

Liver Cancer Clinical Trial

Official title:

Phase II Trial of Intrahepatic Artery Chemotherapy With Nexavar in Hepatocellular Carcinoma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00875615
• Other study ID #: UMIAMI-20080793
• Secondary ID: SCCC-2007101BAYE
• Status: Completed
• Phase: Phase 2
• First received: April 2, 2009
• Last updated: July 25, 2014
• Start date: December 2008
• Est. completion date: June 2012

Study information

• Verified date: November 2013
• Source: University of Miami Sylvester Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Infusing chemotherapy directly into the liver and giving it together with sorafenib may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects of infusing cisplatin or carboplatin directly into the liver and giving it together with sorafenib in treating patients with liver cancer that cannot be removed by surgery.

Description:

OBJECTIVES:

Primary

• To assess the safety of intrahepatic arterial infusion of cisplatin or carboplatin in combination with sorafenib tosylate in patients with unresectable hepatocellular carcinoma.

Secondary

• To assess the time to tumor progression in patients treated with this regimen.

• To assess the overall and progression-free survival of patients treated with this regimen.

OUTLINE: Patients receive intrahepatic arterial infusion of cisplatin or carboplatin over 30-45 minutes on day 1 and oral sorafenib tosylate twice daily on days 8-35. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed hepatocellular carcinoma (HCC) OR serum alpha fetoprotein = 400 ng/mL with radiological evidence suggestive of HCC

• Unresectable disease

• Child-Pugh class A or selected Child-Pugh class B disease (Child-Pugh score = 7 points)

• No Child-Pugh class C disease

• No disease outside the liver or macroscopic invasion of the major vessels such as the portal vein

• No known brain metastasis

• Patients with neurological symptoms must undergo CT scan or MRI of the brain

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1

• WBC = 3,000/mm³ (for patients scheduled to receive carboplatin) or = 2,000/mm³ (for patients scheduled to receive cisplatin)

• Platelet count = 100,000/mm³ (for patients scheduled to receive carboplatin) or = 60,000/mm³ (for patients scheduled to receive cisplatin)

• Serum creatinine = 1.9 mg/dL (for patients scheduled to receive carboplatin) or = 1.5 mg/dL (for patients scheduled to receive cisplatin)

• Serum total bilirubin = 3 mg/dL

• AST and ALT < 5 times upper limit of normal

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for = 3 months after completion of study treatment

• No cardiac disease, including any of the following:

• NYHA class III-IV congestive heart failure

• Unstable angina (anginal symptoms at rest)

• New onset of angina within the past 3 months

• Myocardial infarction within the past 6 months

• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

• No uncontrolled hypertension, defined as systolic BP > 150 mm Hg or diastolic BP > 90 mm Hg, despite optimal medical management

• No thrombolic or embolic events (e.g., cerebrovascular accident, including transient ischemic attacks) within the past 6 months

• No pulmonary hemorrhage/bleeding event = CTCAE grade 2 within the past 4 weeks

• No other hemorrhage/bleeding event = CTCAE grade 3 within the past 4 weeks

• No evidence or history of bleeding diathesis or coagulopathy

• No evidence of encephalopathy

• No condition that would impair the ability to swallow whole pills

• No history of malabsorption problems

• No significant traumatic injury within the past 4 weeks

• No serious non-healing wound, ulcer, or bone fracture

• No active clinically serious infection

• No known HIV infection

• No known or suspected allergy to sorafenib tosylate or any other study agent

PRIOR CONCURRENT THERAPY:

• No prior cisplatin, carboplatin, or sorafenib tosylate

• No prior systemic chemotherapy for HCC

• No other prior systemic or locoregional therapy

• More than 4 weeks since prior major surgery or open biopsy

• No concurrent St. John's wort or rifampin

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Cancer
• Liver Neoplasms

Intervention

Drug:
• Carboplatin
Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.
• Cisplatin
Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.
• Sorafenib
Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.

Locations

Country	Name	City	State
United States	University of Miami Sylvester Comprehensive Cancer Center - Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami Sylvester Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Experiencing Adverse Events	The number of subjects experiencing adverse events after receiving protocol therapy.	36 months	Yes
Secondary	Number of Patients Achieving Clinical Benefit	Number of patients achieving complete or partial response according to RECIST criteria	36 months	No