Trial Outcomes & Findings for Floxuridine and Dexamethasone as a Hepatic Arterial Infusion and Bevacizumab in Treating Patients With Primary Liver Cancer That Cannot be Removed by Surgery (NCT NCT00410956)

NCT ID: NCT00410956

Last Updated: 2024-12-10

Results Overview

Overall median survival from time of initiation of HAI + Bev

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 22 participants
• Primary outcome timeframe: Up to 36 months
• Results posted on: 2024-12-10

Participant Flow

Participant milestones

Measure	UNRESECTABLE PRIMARY HEPATIC MALIGNANCY All patients enrolled in the study will receive HAI FUDR (0.16 mg/kg X pump volume / pump flow rate), Dexamethasone (1 mg/m2/day) and IV Bevacizumab at 5mg/kg. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days post surgical placement of HAI pump; patients will receive their first treatment with Bevacizumab no sooner than 28 days post surgical placement of HAI pump. bevacizumab dexamethasone floxuridine protein expression analysis flow cytometry immunoenzyme technique immunohistochemistry staining method immunologic technique laboratory biomarker analysis dynamic contrast-enhanced magnetic resonance imaging
Overall Study STARTED	22
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Measure	UNRESECTABLE PRIMARY HEPATIC MALIGNANCY All patients enrolled in the study will receive HAI FUDR (0.16 mg/kg X pump volume / pump flow rate), Dexamethasone (1 mg/m2/day) and IV Bevacizumab at 5mg/kg. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days post surgical placement of HAI pump; patients will receive their first treatment with Bevacizumab no sooner than 28 days post surgical placement of HAI pump. bevacizumab dexamethasone floxuridine protein expression analysis flow cytometry immunoenzyme technique immunohistochemistry staining method immunologic technique laboratory biomarker analysis dynamic contrast-enhanced magnetic resonance imaging
Overall Study Adverse Event	1
Overall Study Death	2
Overall Study Lack of Efficacy	10
Overall Study Physician Decision	6

Baseline Characteristics

Floxuridine and Dexamethasone as a Hepatic Arterial Infusion and Bevacizumab in Treating Patients With Primary Liver Cancer That Cannot be Removed by Surgery

Baseline characteristics by cohort

Measure	UNRESECTABLE PRIMARY HEPATIC MALIGNANCY n=22 Participants All patients enrolled in the study will receive HAI FUDR (0.16 mg/kg X pump volume / pump flow rate), Dexamethasone (1 mg/m2/day) and IV Bevacizumab at 5mg/kg. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days post surgical placement of HAI pump; patients will receive their first treatment with Bevacizumab no sooner than 28 days post surgical placement of HAI pump. bevacizumab dexamethasone floxuridine protein expression analysis flow cytometry immunoenzyme technique immunohistochemistry staining method immunologic technique laboratory biomarker analysis dynamic contrast-enhanced magnetic resonance imaging
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	1 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 36 months

Overall median survival from time of initiation of HAI + Bev

Outcome measures

Measure

UNRESECTABLE PRIMARY HEPATIC MALIGNANCY n=22 Participants All patients enrolled in the study will receive HAI FUDR (0.16 mg/kg X pump volume / pump flow rate), Dexamethasone (1 mg/m2/day) and IV Bevacizumab at 5mg/kg. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days post surgical placement of HAI pump; patients will receive their first treatment with Bevacizumab no sooner than 28 days post surgical placement of HAI pump. bevacizumab dexamethasone floxuridine protein expression analysis flow cytometry immunoenzyme technique immunohistochemistry staining method immunologic technique laboratory biomarker analysis dynamic contrast-enhanced magnetic resonance imaging

Median Overall Survival

31.1 months Interval 14.0 to 33.59

PRIMARY outcome

Timeframe: Up to 36 months

Median Hepatic Progression Free Survival. 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

UNRESECTABLE PRIMARY HEPATIC MALIGNANCY n=22 Participants All patients enrolled in the study will receive HAI FUDR (0.16 mg/kg X pump volume / pump flow rate), Dexamethasone (1 mg/m2/day) and IV Bevacizumab at 5mg/kg. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days post surgical placement of HAI pump; patients will receive their first treatment with Bevacizumab no sooner than 28 days post surgical placement of HAI pump. bevacizumab dexamethasone floxuridine protein expression analysis flow cytometry immunoenzyme technique immunohistochemistry staining method immunologic technique laboratory biomarker analysis dynamic contrast-enhanced magnetic resonance imaging

Median Hepatic Progression Free Survival

11.28 months Interval 7.93 to 15.69

PRIMARY outcome

Timeframe: Up to 36 months

Median Progression Free Survival. 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

UNRESECTABLE PRIMARY HEPATIC MALIGNANCY n=22 Participants All patients enrolled in the study will receive HAI FUDR (0.16 mg/kg X pump volume / pump flow rate), Dexamethasone (1 mg/m2/day) and IV Bevacizumab at 5mg/kg. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days post surgical placement of HAI pump; patients will receive their first treatment with Bevacizumab no sooner than 28 days post surgical placement of HAI pump. bevacizumab dexamethasone floxuridine protein expression analysis flow cytometry immunoenzyme technique immunohistochemistry staining method immunologic technique laboratory biomarker analysis dynamic contrast-enhanced magnetic resonance imaging

Median Progression Free Survival

8.45 months Interval 5.53 to 11.05

PRIMARY outcome

Timeframe: Up to 36 months

Antitumor efficacy (complete and partial response, stable and progressive disease). Per Response Evaluation Criteria In Solid Tumors Criteria (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	UNRESECTABLE PRIMARY HEPATIC MALIGNANCY n=22 Participants All patients enrolled in the study will receive HAI FUDR (0.16 mg/kg X pump volume / pump flow rate), Dexamethasone (1 mg/m2/day) and IV Bevacizumab at 5mg/kg. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days post surgical placement of HAI pump; patients will receive their first treatment with Bevacizumab no sooner than 28 days post surgical placement of HAI pump. bevacizumab dexamethasone floxuridine protein expression analysis flow cytometry immunoenzyme technique immunohistochemistry staining method immunologic technique laboratory biomarker analysis dynamic contrast-enhanced magnetic resonance imaging
Antitumor Efficacy (Complete and Partial Response, Stable and Progressive Disease) Partial Response	7 Participants
Antitumor Efficacy (Complete and Partial Response, Stable and Progressive Disease) Stable Disease	15 Participants

SECONDARY outcome

Timeframe: 2 years

Toxicity as measured by NCI Common Toxicity Criteria

Outcome measures

Measure

UNRESECTABLE PRIMARY HEPATIC MALIGNANCY n=22 Participants All patients enrolled in the study will receive HAI FUDR (0.16 mg/kg X pump volume / pump flow rate), Dexamethasone (1 mg/m2/day) and IV Bevacizumab at 5mg/kg. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days post surgical placement of HAI pump; patients will receive their first treatment with Bevacizumab no sooner than 28 days post surgical placement of HAI pump. bevacizumab dexamethasone floxuridine protein expression analysis flow cytometry immunoenzyme technique immunohistochemistry staining method immunologic technique laboratory biomarker analysis dynamic contrast-enhanced magnetic resonance imaging

Number of Participants Evaluated for Toxicity as Measured by NCI Common Toxicity Criteria

22 Participants

Adverse Events

UNRESECTABLE PRIMARY HEPATIC MALIGNANCY

Serious events: 12 serious events

Other events: 17 other events

Deaths: 21 deaths

Serious adverse events

Measure	UNRESECTABLE PRIMARY HEPATIC MALIGNANCY n=22 participants at risk All patients enrolled in the study will receive HAI FUDR (0.16 mg/kg X pump volume / pump flow rate), Dexamethasone (1 mg/m2/day) and IV Bevacizumab at 5mg/kg. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days post surgical placement of HAI pump; patients will receive their first treatment with Bevacizumab no sooner than 28 days post surgical placement of HAI pump. bevacizumab dexamethasone floxuridine protein expression analysis flow cytometry immunoenzyme technique immunohistochemistry staining method immunologic technique laboratory biomarker analysis dynamic contrast-enhanced magnetic resonance imaging
Nervous system disorders Pain, headache, nausea	4.5% 1/22 • Up to 36 months
Respiratory, thoracic and mediastinal disorders Shortness of breath	4.5% 1/22 • Up to 36 months
General disorders Chest pain	4.5% 1/22 • Up to 36 months
Eye disorders Mucosal tear, duodenal bulb	4.5% 1/22 • Up to 36 months
Metabolism and nutrition disorders Hypoglycemia	4.5% 1/22 • Up to 36 months
Hepatobiliary disorders Portal hypertension, esophageal varices	4.5% 1/22 • Up to 36 months
Metabolism and nutrition disorders Hyperglycemia	4.5% 1/22 • Up to 36 months
Hepatobiliary disorders PV thrombosis	4.5% 1/22 • Up to 36 months
Metabolism and nutrition disorders Hyponatremia	4.5% 1/22 • Up to 36 months
Psychiatric disorders Confusion	4.5% 1/22 • Up to 36 months
Cardiac disorders Myocardial infarct	4.5% 1/22 • Up to 36 months
Immune system disorders Allergic reaction	4.5% 1/22 • Up to 36 months
Gastrointestinal disorders Ileitis	4.5% 1/22 • Up to 36 months

Other adverse events

Measure	UNRESECTABLE PRIMARY HEPATIC MALIGNANCY n=22 participants at risk All patients enrolled in the study will receive HAI FUDR (0.16 mg/kg X pump volume / pump flow rate), Dexamethasone (1 mg/m2/day) and IV Bevacizumab at 5mg/kg. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days post surgical placement of HAI pump; patients will receive their first treatment with Bevacizumab no sooner than 28 days post surgical placement of HAI pump. bevacizumab dexamethasone floxuridine protein expression analysis flow cytometry immunoenzyme technique immunohistochemistry staining method immunologic technique laboratory biomarker analysis dynamic contrast-enhanced magnetic resonance imaging
Hepatobiliary disorders Liver function derangement	54.5% 12/22 • Up to 36 months
General disorders Pain	4.5% 1/22 • Up to 36 months
Gastrointestinal disorders Diarrhea	13.6% 3/22 • Up to 36 months
Respiratory, thoracic and mediastinal disorders Dyspnea	4.5% 1/22 • Up to 36 months

Additional Information

Dr. William Jarnagin, MD

Memorial Sloan Kettering Cancer Center

Phone: 212-639-7601

Email: jarnagiw@mskcc.org

Results disclosure agreements

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