Trial Outcomes & Findings for Bevacizumab in Treating Patients With Unresectable Nonmetastatic Liver Cancer (NCT NCT00055692)

NCT ID: NCT00055692

Last Updated: 2016-02-29

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 46 participants
• Primary outcome timeframe: At 6 months
• Results posted on: 2016-02-29

Participant Flow

A total of 46 patients were enrolled between February 2003 and September 2006

Participant milestones

Measure	Treatment (Bevacizumab) Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity. bevacizumab: Given orally
Overall Study STARTED	46
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bevacizumab in Treating Patients With Unresectable Nonmetastatic Liver Cancer

Baseline characteristics by cohort

Measure	Treatment (Bevacizumab) n=46 Participants Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity. bevacizumab: Given orally
Age, Continuous	58 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants
Race/Ethnicity, Customized White	25 participants n=5 Participants
Race/Ethnicity, Customized Black	2 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	5 participants n=5 Participants
Race/Ethnicity, Customized Asian	14 participants n=5 Participants

PRIMARY outcome

Timeframe: At 6 months

Outcome measures

Measure	Treatment (Bevacizumab) n=46 Participants Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity. bevacizumab: Given orally	Treatment (Bevacizumab): 8 Weeks Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity. bevacizumab: Given orally
Progression-free Survival	65 percentage of participants Interval 51.0 to 79.0	—

PRIMARY outcome

Timeframe: MRI is required at weeks 8, 16 and then every 12 weeks until disease progression

MRI scan is required at weeks 8, 16 and then every 12 weeks until disease progression. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Outcome measures

Measure	Treatment (Bevacizumab) n=46 Participants Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity. bevacizumab: Given orally	Treatment (Bevacizumab): 8 Weeks Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity. bevacizumab: Given orally
Disease Response	6 participants Interval 3.0 to 23.0	—

PRIMARY outcome

Timeframe: Baseline and 8 weeks after bevacizumab therapy

Population: Eight consecutive patients enrolled at one site were evaluated before and at 8 weeks after bevacizumab therapy with DCE-MRI.

Outcome measures

Measure	Treatment (Bevacizumab) n=8 Participants Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity. bevacizumab: Given orally	Treatment (Bevacizumab): 8 Weeks n=8 Participants Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity. bevacizumab: Given orally
Mean Arterial Enhancement, Per Lesion, as Determined by Dynamic Gadolinium-enhanced Magnetic Resonance Imaging (MRI), Before and Following Bevacizumab Therapy.	37.3 relative MR units Standard Deviation 18.4	18.4 relative MR units Standard Deviation 12.4

PRIMARY outcome

Timeframe: During treatment

Population: Six of eight patients were analyzed after 8 weeks of bevacizumab therapy

Outcome measures

Measure	Treatment (Bevacizumab) n=6 Participants Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity. bevacizumab: Given orally	Treatment (Bevacizumab): 8 Weeks Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity. bevacizumab: Given orally
Assessment on Circulating Levels of VEGF Which Also Contribute to HCC Pathogenesis and on Potential Alterations of These Levels in the Setting of VEGF-inhibition	249 pg/mL Standard Deviation 175	—

PRIMARY outcome

Timeframe: During and after treatment

Population: No data was collected by the principal investigator for this outcome

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: At 6 months

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Bevacizumab)

Serious events: 22 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment (Bevacizumab) n=46 participants at risk Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity. bevacizumab: Given orally
Vascular disorders Hypertension	15.2% 7/46 • Number of events 7
Renal and urinary disorders Proteinuria	4.3% 2/46 • Number of events 2
Gastrointestinal disorders Hemorrhage	10.9% 5/46 • Number of events 5
Vascular disorders Arterial thrombosis	4.3% 2/46 • Number of events 2
Vascular disorders Venous thrombosis	2.2% 1/46 • Number of events 1
Investigations Increased AST	2.2% 1/46 • Number of events 1
Investigations Increased ALT	2.2% 1/46 • Number of events 1
Investigations Increased alkaline phosphatase	2.2% 1/46 • Number of events 1
Investigations Increased bilirubin	10.9% 5/46 • Number of events 5
Gastrointestinal disorders Ascites	4.3% 2/46 • Number of events 2
Gastrointestinal disorders Anorexia	2.2% 1/46 • Number of events 1

Other adverse events

Measure	Treatment (Bevacizumab) n=46 participants at risk Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity. bevacizumab: Given orally
Vascular disorders Hypertension	17.4% 8/46 • Number of events 8
Renal and urinary disorders Proteinuria	37.0% 17/46 • Number of events 17
Respiratory, thoracic and mediastinal disorders Epistaxis	10.9% 5/46 • Number of events 5
Gastrointestinal disorders Hemorrhage	15.2% 7/46 • Number of events 7
Skin and subcutaneous tissue disorders Rash	13.0% 6/46 • Number of events 6
Investigations Thrombocytopenia	13.0% 6/46 • Number of events 6
Investigations Increased AST	19.6% 9/46 • Number of events 9
Investigations Increased ALT	17.4% 8/46 • Number of events 8
Investigations Increased alkaline phosphatase	8.7% 4/46 • Number of events 4
Investigations Increased bilirubin	15.2% 7/46 • Number of events 7
Gastrointestinal disorders Ascites	6.5% 3/46 • Number of events 3
General disorders Fatigue	32.6% 15/46 • Number of events 15
Gastrointestinal disorders vomiting	10.9% 5/46 • Number of events 5
Gastrointestinal disorders Anorexia	8.7% 4/46 • Number of events 4
Gastrointestinal disorders Nausea	10.9% 5/46 • Number of events 5

Additional Information

Lisa Escobar-Peralta, Program Manager

Montefiore Medical Center

Phone: 718-379-6866

Email: lescobar@montefiore.org

Results disclosure agreements

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

Restriction type: LTE60