Trial Outcomes & Findings for Bevacizumab and Erlotinib in Inoperable and Metastatic Hepatocellular Carcinoma (NCT NCT00287222)

NCT ID: NCT00287222

Last Updated: 2011-07-15

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 21 participants
• Primary outcome timeframe: 27 weeks
• Results posted on: 2011-07-15

Participant Flow

Recruitment Period was from 7/08/2005 to 12/17/2008. Recruitment occurred at the University of Arkansas for Medical Sciences medical oncology clinic and Kansas University Cancer Center.

Participant milestones

Measure	Bevacizumab and Erlotinib Subjects will be treated with bevacizumab and erlotinib
Overall Study STARTED	21
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bevacizumab and Erlotinib in Inoperable and Metastatic Hepatocellular Carcinoma

Baseline characteristics by cohort

Measure	Bevacizumab and Erlotinib n=21 Participants Subjects will be treated with bevacizumab and erlotinib
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants

PRIMARY outcome

Timeframe: 27 weeks

Population: Per protocol

Outcome measures

Measure	Bevacizumab and Erlotinib n=21 Participants Subjects will be treated with bevacizumab and erlotinib
Number of Participants Who Remained Free of Progression at the 27th Week.	21 participants

Adverse Events

Bevacizumab and Erlotinib

Serious events: 11 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bevacizumab and Erlotinib n=21 participants at risk Subjects will be treated with bevacizumab and erlotinib
General disorders Fatigue	19.0% 4/21 • Number of events 4
Metabolism and nutrition disorders dehydration	9.5% 2/21 • Number of events 2
Gastrointestinal disorders hematemesis	4.8% 1/21 • Number of events 1
Gastrointestinal disorders nausea	4.8% 1/21 • Number of events 1
Respiratory, thoracic and mediastinal disorders dyspnea	4.8% 1/21 • Number of events 1
Gastrointestinal disorders diarrhea	4.8% 1/21 • Number of events 1
Cardiac disorders myocardial infarction	4.8% 1/21 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Sandy Annis

University of Arkansas for Medical Sciences

Phone: 5016868274

Email: amannis@uams.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place