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

NCT00875615 | Completed Phase 2 Results

• 3 other identifiers: 20080793SCCC-2007101BAYER-SCCC-2007101
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Cancer

Keywords

adult primary hepatocellular carcinoma; localized unresectable adult primary liver cancer; advanced adult primary liver cancer

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Experiencing Adverse Events

  The number of subjects experiencing adverse events after receiving protocol therapy.

  36 months

Secondary Outcomes (1)

• Number of Patients Achieving Clinical Benefit

  36 months

Study Arms (1)

Cisplatin or Carboplatin + Sorafenib

EXPERIMENTAL

Drug: Carboplatin; Drug: Cisplatin; Drug: Sorafenib

Interventions

Carboplatin DRUG

Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.

Cisplatin or Carboplatin + Sorafenib

Cisplatin DRUG

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.

Cisplatin or Carboplatin + Sorafenib

Sorafenib DRUG

Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.

Cisplatin or Carboplatin + Sorafenib

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Interventions

Carboplatin; Cisplatin; Sorafenib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Phenylurea Compounds; Urea; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Lynn Feun MD
• Organization: University of Miami Sylvester Comprehensive Cancer Center

lfeun@med.miami.edu

305-243-4981

Study Officials

• Lynn G. Feun, MD

  University of Miami Sylvester Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: April 2, 2009
• First Posted: April 3, 2009
• Study Start: December 1, 2008
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 7, 2017
• Results First Posted: October 17, 2013

Record last verified: 2016-12

Locations

US (1)