Trial Outcomes & Findings for Erlotinib Plus Bevacizumab in Hepatocellular Carcinoma (HCC) as Second-line Therapy (NCT NCT01180959)
NCT ID: NCT01180959
Last Updated: 2022-11-07
Results Overview
Progression-free survival is defined as time from initiation of therapy until documented disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
59 months
Results posted on
2022-11-07
Participant Flow
45 participants signed consent, 1 patient withdrew consent prior to receiving treatment.
Participant milestones
| Measure |
Erlotinib + Bevacizumab
Erlotinib 150 mg by mouth once a day. Bevacizumab 10 mg/kg by vein once every 2 weeks on days 1 and 15 of each cycle. The first dose of bevacizumab will be given over about 90 minutes.
Bevacizumab: 10 mg/kg by vein once every 2 weeks on days 1 and 15 of each cycle. The first dose of bevacizumab will be given over about 90 minutes
Erlotinib: 150 mg by mouth once a day.
|
|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
COMPLETED
|
44
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Erlotinib Plus Bevacizumab in Hepatocellular Carcinoma (HCC) as Second-line Therapy
Baseline characteristics by cohort
| Measure |
Erlotinib + Bevacizumab
n=44 Participants
Erlotinib 150 mg by mouth once a day. Bevacizumab 10 mg/kg by vein once every 2 weeks on days 1 and 15 of each cycle. The first dose of bevacizumab will be given over about 90 minutes.
Bevacizumab: 10 mg/kg by vein once every 2 weeks on days 1 and 15 of each cycle. The first dose of bevacizumab will be given over about 90 minutes
Erlotinib: 150 mg by mouth once a day.
|
|---|---|
|
Age, Continuous
|
63.05 years
STANDARD_DEVIATION 11.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 59 monthsProgression-free survival is defined as time from initiation of therapy until documented disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Erlotinib + Bevacizumab
n=44 Participants
Erlotinib 150 mg by mouth once a day. Bevacizumab 10 mg/kg by vein once every 2 weeks on days 1 and 15 of each cycle. The first dose of bevacizumab will be given over about 90 minutes.
Bevacizumab: 10 mg/kg by vein once every 2 weeks on days 1 and 15 of each cycle. The first dose of bevacizumab will be given over about 90 minutes
Erlotinib: 150 mg by mouth once a day.
|
|---|---|
|
Progression Free Survival (PFS)
|
43 months
Interval 28.0 to 59.0
|
SECONDARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 16 weeksTTP is defined as the time between treatment assignment and radiologic progression at 16 weeks as defined by the amendments of the Response Evaluation Criteria in Solid Tumors (RECIST).Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Erlotinib + Bevacizumab
n=44 Participants
Erlotinib 150 mg by mouth once a day. Bevacizumab 10 mg/kg by vein once every 2 weeks on days 1 and 15 of each cycle. The first dose of bevacizumab will be given over about 90 minutes.
Bevacizumab: 10 mg/kg by vein once every 2 weeks on days 1 and 15 of each cycle. The first dose of bevacizumab will be given over about 90 minutes
Erlotinib: 150 mg by mouth once a day.
|
|---|---|
|
Time to Progression (TTP)
|
3.9 months
Interval 2.0 to 8.3
|
SECONDARY outcome
Timeframe: 24 monthsOverall Survival is the time in months from start of study treatment to date of death due to any cause.
Outcome measures
| Measure |
Erlotinib + Bevacizumab
n=44 Participants
Erlotinib 150 mg by mouth once a day. Bevacizumab 10 mg/kg by vein once every 2 weeks on days 1 and 15 of each cycle. The first dose of bevacizumab will be given over about 90 minutes.
Bevacizumab: 10 mg/kg by vein once every 2 weeks on days 1 and 15 of each cycle. The first dose of bevacizumab will be given over about 90 minutes
Erlotinib: 150 mg by mouth once a day.
|
|---|---|
|
Overall Survival (OS)
|
9.9 months
Interval 8.3 to 15.5
|
Adverse Events
Erlotinib + Bevacizumab
Serious events: 0 serious events
Other events: 40 other events
Deaths: 33 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Erlotinib + Bevacizumab
n=44 participants at risk
Erlotinib 150 mg by mouth once a day. Bevacizumab 10 mg/kg by vein once every 2 weeks on days 1 and 15 of each cycle. The first dose of bevacizumab will be given over about 90 minutes.
Bevacizumab: 10 mg/kg by vein once every 2 weeks on days 1 and 15 of each cycle. The first dose of bevacizumab will be given over about 90 minutes
Erlotinib: 150 mg by mouth once a day.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Acneiform Rash
|
90.9%
40/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.3%
1/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
54.5%
24/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.1%
4/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.8%
3/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
Skin and subcutaneous tissue disorders
Bruising
|
2.3%
1/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
Gastrointestinal disorders
Anorexia
|
45.5%
20/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
Gastrointestinal disorders
Nausea
|
36.4%
16/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
Gastrointestinal disorders
Vomiting
|
29.5%
13/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
Gastrointestinal disorders
Dysphagia
|
4.5%
2/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
22/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
Gastrointestinal disorders
Constipation
|
9.1%
4/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
Gastrointestinal disorders
other
|
13.6%
6/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
Gastrointestinal disorders
Lower GI hemorrhage
|
13.6%
6/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
Gastrointestinal disorders
Upper GI Hemorrhage
|
2.3%
1/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
General disorders
Fever without neutropenia
|
2.3%
1/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
General disorders
Weight Loss
|
22.7%
10/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
General disorders
General Disorder, other
|
13.6%
6/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.8%
3/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
General disorders
Pain (Head)
|
15.9%
7/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
General disorders
Pain (Back)
|
4.5%
2/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
General disorders
Pain (Abdomen)
|
9.1%
4/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
General disorders
Pain (Muscle)
|
4.5%
2/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
General disorders
Pain (Other)
|
22.7%
10/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
Investigations
Anemia
|
6.8%
3/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
Investigations
Elevated transaminase
|
11.4%
5/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
Skin and subcutaneous tissue disorders
Hand-Foot Syndrome
|
6.8%
3/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
Infections and infestations
Wound Infection
|
2.3%
1/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pul. Hemorrhage
|
6.8%
3/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
Investigations
Hyperbilirubinemia
|
29.5%
13/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
Investigations
Hypokalemia
|
6.8%
3/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
Gastrointestinal disorders
Dry Mouth
|
4.5%
2/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
General disorders
Dry Eyes
|
2.3%
1/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
Vascular disorders
Hypertension
|
15.9%
7/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
2.3%
1/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
Investigations
Hypomagnesemia
|
15.9%
7/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
9.1%
4/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
Renal and urinary disorders
Proteinuria
|
40.9%
18/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
Gastrointestinal disorders
Mucositis
|
56.8%
25/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
Gastrointestinal disorders
Taste Changes
|
15.9%
7/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
Nervous system disorders
Voice Changes
|
15.9%
7/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
Infections and infestations
Infection
|
9.1%
4/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
Nervous system disorders
Syncopy attacks
|
2.3%
1/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
|
Vascular disorders
Thrombus formation
|
2.3%
1/44 • Adverse Events were collected from first dose through 30 days after the last dose of study medication, up to 43 months.
|
Additional Information
Dr. Ahmed Kaseb, MD- Professor, GI Medical Oncology
UT MD Anderson Cancer Center
Phone: (713) 792-2828
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place