Trial Outcomes & Findings for Efficacy and Safety Study of Bevacizumab and Erlotinib to Treat Primary Liver Cancer That Cannot be Removed By Surgery (NCT NCT00242502)

Last Updated: 2013-05-06

Results Overview

Progression free survival (PFS) at 16 weeks of treatment with the combination of Avastin and erlotinib where participant said to be failure free at 16 weeks if they are alive, and their disease has not progressed. PFS Rate is number of participants with PFS at 16 weeks out of total participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

62 participants

Primary outcome timeframe

Baseline to 16 weeks

Results posted on

2013-05-06

Participant Flow

Recruitment Period: September 30, 2005 to May 12, 2009. All recruitment done at UT MD Anderson Cancer Center.

Of the 62 participants, three (3) were excluded prior to treatment and are excluded from the trial.

Participant milestones

Participant milestones
Measure	Bevacizumab + Erlotinib Bevacizumab 10 mg/kg intravenous every 14 days, repeat cycle every 28 days; Erlotinib 150 mg orally every day continuous dosing.
Overall Study STARTED	59
Overall Study COMPLETED	59
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety Study of Bevacizumab and Erlotinib to Treat Primary Liver Cancer That Cannot be Removed By Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bevacizumab + Erlotinib n=59 Participants Bevacizumab 10 mg/kg intravenous every 14 days, repeat cycle every 28 days; Erlotinib 150 mg orally every day continuous dosing.
Age Continuous	63 years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants
Region of Enrollment United States	59 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 16 weeks

Population: Six participants were not evaluable.

Outcome measures

Outcome measures
Measure	Bevacizumab + Erlotinib n=53 Participants Bevacizumab 10 mg/kg intravenous every 14 days, repeat cycle every 28 days; Erlotinib 150 mg orally every day continuous dosing.
Progression-free Survival (PFS) Rate	64 percentage of participants Interval 51.0 to 76.0

Adverse Events

Bevacizumab + Erlotinib

Serious events: 18 serious events

Other events: 59 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Bevacizumab + Erlotinib n=59 participants at risk Bevacizumab 10 mg/kg intravenous every 14 days, repeat cycle every 28 days; Erlotinib 150 mg orally every day continuous dosing.
Gastrointestinal disorders Diarrhea	16.9% 10/59 • 3 years and 6 months
Blood and lymphatic system disorders Elevated transaminases	11.9% 7/59 • 3 years and 6 months
General disorders Fatigue	30.5% 18/59 • 3 years and 6 months
Gastrointestinal disorders Gastrointestinal hemorrhage	10.2% 6/59 • 3 years and 6 months
Blood and lymphatic system disorders Hypertension	13.6% 8/59 • 3 years and 6 months

Other adverse events

Other adverse events
Measure	Bevacizumab + Erlotinib n=59 participants at risk Bevacizumab 10 mg/kg intravenous every 14 days, repeat cycle every 28 days; Erlotinib 150 mg orally every day continuous dosing.
General disorders Abdominal pain	33.9% 20/59 • 3 years and 6 months
Skin and subcutaneous tissue disorders Acne-rash	37.3% 22/59 • 3 years and 6 months
Gastrointestinal disorders Anorexia	47.5% 28/59 • 3 years and 6 months
Gastrointestinal disorders Constipation	18.6% 11/59 • 3 years and 6 months
Gastrointestinal disorders Diarrhea	32.2% 19/59 • 3 years and 6 months
Hepatobiliary disorders Elevated ALT, AST and bilirubin	11.9% 7/59 • 3 years and 6 months
General disorders Fatigue	30.5% 18/59 • 3 years and 6 months
Gastrointestinal disorders Hemorrhage, Gastrointestinal	5.1% 3/59 • 3 years and 6 months
Blood and lymphatic system disorders Low hemoglobin	5.1% 3/59 • 3 years and 6 months
Gastrointestinal disorders Mucositis	33.9% 20/59 • 3 years and 6 months
Skin and subcutaneous tissue disorders Nail changes	23.7% 14/59 • 3 years and 6 months
Gastrointestinal disorders Nausea	23.7% 14/59 • 3 years and 6 months
Gastrointestinal disorders Vomiting	22.0% 13/59 • 3 years and 6 months
Immune system disorders allergic rhinitis	11.9% 7/59 • 3 years and 6 months
Skin and subcutaneous tissue disorders alopecia	22.0% 13/59 • 3 years and 6 months
Musculoskeletal and connective tissue disorders back pain	15.3% 9/59 • 3 years and 6 months
Skin and subcutaneous tissue disorders dermatology/other	13.6% 8/59 • 3 years and 6 months
Eye disorders dry eye	42.4% 25/59 • 3 years and 6 months
Gastrointestinal disorders dry mouth	55.9% 33/59 • 3 years and 6 months
Skin and subcutaneous tissue disorders dry skin	62.7% 37/59 • 3 years and 6 months
General disorders headache	33.9% 20/59 • 3 years and 6 months
Gastrointestinal disorders heartburn	18.6% 11/59 • 3 years and 6 months
Respiratory, thoracic and mediastinal disorders hemorrhage, pulmonary	66.1% 39/59 • 3 years and 6 months
Gastrointestinal disorders hemorrhage, rectum	18.6% 11/59 • 3 years and 6 months
Metabolism and nutrition disorders hypomagnesemia	35.6% 21/59 • 3 years and 6 months
Psychiatric disorders insomnia	25.4% 15/59 • 3 years and 6 months
Musculoskeletal and connective tissue disorders joint pain	13.6% 8/59 • 3 years and 6 months
Musculoskeletal and connective tissue disorders muscle pain	25.4% 15/59 • 3 years and 6 months
Skin and subcutaneous tissue disorders pruritis	15.3% 9/59 • 3 years and 6 months
Skin and subcutaneous tissue disorders rash-desquamation	13.6% 8/59 • 3 years and 6 months
General disorders rigors/chills	15.3% 9/59 • 3 years and 6 months
Gastrointestinal disorders taste alteration	30.5% 18/59 • 3 years and 6 months
Respiratory, thoracic and mediastinal disorders voice changes	15.3% 9/59 • 3 years and 6 months
Gastrointestinal disorders weight loss	22.0% 13/59 • 3 years and 6 months

Additional Information

Ahmed Kaseb, MD/ Professor

University of Texas MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place