ABT-888 and Temozolomide for Liver Cancer
This study is for people with liver cancer (also called hepatocellular carcinoma, or HCC in abbreviation).
The purpose of this study is to test the efficacy (effectiveness) of a new combination of drugs, ABT-888 and temozolomide for patients with liver cancer. Temozolomide acts by damaging deoxyribonucleic acid (DNA) in rapidly dividing cells, in other words, cancer cells. ABT-888 inhibits an enzyme called "PARP" which helps to fix damaged DNA. By inhibiting this enzyme, ABT-888 prevents cancer cells from repairing the damage caused by the temozolomide and will hopefully increase the killing of cancer cells, and decrease the tumors in the body.
ABT-888 is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration (FDA) for use in liver cancer.
This study will help find out what effects (good and bad) the combination of drugs, temozolomide and ABT-888, has on liver cancer.
This research is being done because it is not known if ABT-888 will increase the effectiveness of temozolomide in liver cancer.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of ABT-888 and Temozolomide in Patients With Advanced Hepatocellular Carcinoma (HCC) Progressing Following Sorafenib Treatment or Intolerant to Sorafenib|
- clinical benefit rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]complete response at any time + partial response at any time + stable disease after 8 weeks of treatment based on RECIST Criteria
- overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]the number of days between a patient's enrollment and his/her date of death
- Progression free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]The number of days between a patient's enrollment and his/her disease progression
- Safety assessment [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Record of all toxicities graded according to the NCI CTCAE version 3.0
- Biomarker analysis [ Time Frame: 2 months ] [ Designated as safety issue: No ]Markers in blood or tissue that are looked at will be classified as yes (present)or no (not present)
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||July 2014|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: temozolomide + ABT-888
Temozolomide and ABT-888
Drug: temozolomide + ABT-888
Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days ABT-888 40 mg BID PO Days 1-7 every 28 days
Patents with stable disease or continued response to therapy will be treated and followed for a total of 6 cycles (6 months).
|United States, District of Columbia|
|Lombardi Comprehensive Cancer Center at Georgetown University Medical Center|
|Washington, District of Columbia, United States, 20007|
|Principal Investigator:||Aiwu R He, MD PhD||Georgetown University|