Sorafenib and Vorinostat in Treating Patients With Advanced Liver Cancer
This phase I trial is studying the side effects and best dose of vorinostat when given together with sorafenib tosylate in treating patients with advanced liver cancer. Sorafenib tosylate and vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Giving sorafenib tosylate together with vorinostat may kill more tumor cells.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Sorafenib and Vorinostat in Advanced Hepatocellular Carcinoma|
- Determine the appropriate doses of vorinostat and sorafenib when given in combination to patients with hepatocellular carcinoma [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Identify the maximum tolerated dose of the combination regimen of vorinostat and sorafenib to study further for efficacy of treatment for hepatocellular carcinoma
- Define maximum tolerated dose of the combination of vorinostat and sorafenib in patients treated for hepatocellular carcinoma in patients with HCC [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Observe toxicities experienced by patients treated in cohorts of escalating doses of the drug combination.
- Anti-tumor effects of the combination [ Time Frame: 2 years ] [ Designated as safety issue: No ]Observe whether treatment with vorinostat and sorafenib affects the growth of the hepatocellular tumor.
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive sorafenib tosylate PO BID continuously and vorinostat PO QD, for 5 days each week. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Drug: sorafenib tosylate
Other Names:Drug: vorinostat
I. To determine doses for the combination of vorinostat with standard dose sorafenib (400 mg twice daily) and reduced dose sorafenib (200 mg twice daily appropriate for phase II study in HCC.
I. To evaluate the safety, tolerance, and toxicity of the combination of sorafenib and vorinostat in patients with HCC.
II. To observe antitumor effects of the combination. III. To evaluate the feasibility of circulating tumor cell analysis for tumor cell enumeration, and target protein expression on HCC tumor cells.
Outline: This is a dose-escalation study of vorinostat. Patients receive oral sorafenib tosylate twice daily for 3 weeks and oral vorinostat once daily, 5 days a week, for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically.
|Contact: Andrew S. Poklepovic, MDemail@example.com|
|Contact: Maria Quigley, RNfirstname.lastname@example.org|
|United States, Virginia|
|Virginia Commonwealth University||Recruiting|
|Richmond, Virginia, United States, 23298|
|Contact: Andrew Poklepovic, MD 804-628-2321 email@example.com|
|Contact: Maria Quigley, RN 804-628-3836 firstname.lastname@example.org|
|Principal Investigator: Andrew Poklepovic, MD|
|Hunter Holmes McGuire VA Medical Center||Recruiting|
|Richmond, Virginia, United States, 23249|
|Contact: Rosemarie Mannino, MD 804-675-5000 ext 4310 email@example.com|
|Principal Investigator: Rosemarie Mannino, MD|
|Principal Investigator:||Andrew S. Poklepovic, MD||Virginia Commonwealth University|