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:||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: 8 weeks ] [ 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 months 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 months between a patient's enrollment and his/her disease progression
- Number of Participants Who Had Grade 3 or 4 Adverse Events [ 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: 6 months ] [ Designated as safety issue: No ]To evaluate biological correlation with response to ABT-888 and temozolomide, including evaluation of loss of heterozygosity (LOH) of 13q, decreased expression of or mutations in BRCA-1 or -2, and a select assortment of DNA repair genes.
|Study Start Date:||August 2010|
|Study Completion Date:||October 2014|
|Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Experimental: Temozolomide and ABT-888 in HCC patients
Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days ABT-888 40 mg BID PO Days 1-7 every 28 days
Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days
Other Name: TemodarDrug: ABT-888
ABT-888 40 mg BID PO Days 1-7 every 28 days
Other Name: Veliparib
Patients with hepatocellular carcinoma seen at Lombardi Cancer Center were evaluated for the eligibility of this study.
The Georgetown Lombardi Comprehensive Cancer Center was responsible for the data and safety monitoring of this trial. As this study is an investigator initiated study Phase II study utilizing a non-FDA approved drug for which the PI held the IND it was considered a high risk study which had real-time monitoring by the PI and study team and quarterly reviews by the LCCC Data and Safety Monitoring Committee (DSMC).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01205828
|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|