Temsirolimus as Second-line Therapy in HCC
The purpose of this study is to evaluate the activity of temsirolimus in patients who have advanced hepatocellular carcinoma (HCC) and have been treated with one previous chemotherapy or biologic therapy like sorafenib, but have experienced disease progression or intolerance to that therapy.
Unresectable or Metastatic Hepatocellular Carcinoma
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Temsirolimus as Second-line Therapy in Patients With Advanced, Unresectable Hepatocellular Carcinoma|
- Disease Progression [ Designated as safety issue: No ]The primary outcome measure is to determine the proportion of patients who are progression free at 3 months.
- Response rate [ Designated as safety issue: No ]Response rate, clinical benefit rate (complete + partial response + stable disease > 12 weeks) and overall survival with temsirolimus
- Safety and tolerability [ Designated as safety issue: Yes ]Number and frequency of adverse events and serious adverse events will be monitored.
- Biochemical response [ Designated as safety issue: No ]Biochemical response (>50% decline in AFP levels from baseline) with temsirolimus
- Pharmacokinetics [ Designated as safety issue: No ]Pharmacokinetics will be assessed: AUC pre-dose, 1, 3, 24,48, 72 and 162 hours post dose.
- Circulating tumor cells levels [ Designated as safety issue: No ]Feasibility and utility of circulating tumor cells in this patient population
|Study Start Date:||February 2010|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Currently, no standard therapy exists for patients who progress on sorafenib. mTOR signaling is often up-regulated in HCC promoting cell growth and survival. This process is inhibited by rapamycin, a specific inhibitor of mTOR. Temsirolimus, a rapamycin analog, may delay tumor progression by inhibiting mTOR in HCC.Intervention: Temsirolimus IV
Eligible patients will receive temsirolimus IV on days 1,8,15 every 21 days. Treatment will continue till disease progression or untolerable side effects
|Contact: Steve West, BS, CCRPfirstname.lastname@example.org|
|United States, Tennessee|
|Boston Baskin Cancer Foundation||Recruiting|
|Memphis, Tennessee, United States, 38120|
|Principal Investigator:||Jasgit Sachdev, MD||University of Tennessee Cancer Institute|