Trial Outcomes & Findings for Phase II Study of Sunitinib Malate Following Hepatic Artery Embolization (NCT NCT00434109)

Last Updated: 2012-09-14

Results Overview

Kaplan-Meier analysis of PFS. Progression-free survival rate at 12 months after first embolization. PFS was defined as time from start of treatment until disease progression or death as a result of any cause. Response and progression endpoints refer specifically to hepatic metastases. Extrahepatic metastases were included for assessment of response and progression by RECIST version 1.0. Progressive Disease (PD): At least a 20% increase in the SLD of target lesions, taking as reference the smallest SLD recorded since the treatment started.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

12 months

Results posted on

2012-09-14

Participant Flow

All patients seen at Moffitt Cancer Center with hepatic metastases from gastrointestinal neuroendocrine tumors were screened for eligibility to be enrolled in the study.

Participant milestones

Participant milestones
Measure	Sunitinib Malate and Hepatic Artery Embolizations Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
Overall Study STARTED	39
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Sunitinib Malate and Hepatic Artery Embolizations Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
Overall Study Physician Decision	9
Overall Study Adverse Event	5
Overall Study Protocol Violation	1
Overall Study had embolism, did not receive sunitinib	3

Baseline Characteristics

Phase II Study of Sunitinib Malate Following Hepatic Artery Embolization

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sunitinib Malate and Hepatic Artery Embolizations n=39 Participants Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Age, Customized	61 years n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: All participants

Outcome measures

Outcome measures
Measure	Sunitinib Malate and Hepatic Artery Embolizations n=39 Participants Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
Percentage of Participants With Progression Free Survival (PFS) at 12 Months	66 percentage of participants Interval 51.0 to 81.0

SECONDARY outcome

Timeframe: 12 months

Population: All participants

Overall survival at 12 months. OS was defined as time from start of treatment until death as a result of any cause, with patients censored at the date of last follow-up if still alive.

Outcome measures

Outcome measures
Measure	Sunitinib Malate and Hepatic Artery Embolizations n=39 Participants Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
Percentage of Participants With Overall Survival (OS) at One Year	95 percentage of participants Interval 88.0 to 100.0

SECONDARY outcome

Timeframe: 12 months

Population: All Participants

Objective radiographic response rate. Response and progression endpoints refer specifically to hepatic metastases. Extrahepatic metastases were included for assessment of response and progression by RECIST version 1.0. Partial Response (PR): At least a 30% decrease in the sum of longest diameter (SLD) of target lesions, taking as reference the baseline SLD.

Outcome measures

Outcome measures
Measure	Sunitinib Malate and Hepatic Artery Embolizations n=39 Participants Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
Number of Participants With Partial Radiographic Response	28 participants

SECONDARY outcome

Timeframe: 12 months

Population: All Participants

Biochemical response rate (\>50% reduction in tumor marker). Response and progression endpoints refer specifically to hepatic metastases.

Outcome measures

Outcome measures
Measure	Sunitinib Malate and Hepatic Artery Embolizations n=39 Participants Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
Number of Participants With Biochemical Response	19 participants

SECONDARY outcome

Timeframe: 12 months

Population: All participants

Treatment related toxicity. Participants requiring dose reductions of sunitinib to 25 mg due to side effects.

Outcome measures

Outcome measures
Measure	Sunitinib Malate and Hepatic Artery Embolizations n=39 Participants Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
Number of Participants Requiring Dose Reduction	16 participants

SECONDARY outcome

Timeframe: 48 months

Population: All Participants

Participant overall survival at 48 months. OS was defined as time from start of treatment until death as a result of any cause, with patients censored at the date of last follow-up if still alive.

Outcome measures

Outcome measures
Measure	Sunitinib Malate and Hepatic Artery Embolizations n=39 Participants Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
Percentage of Participants With Overall Survival (OS) at 4 Years	59 percentage of participants Interval 38.0 to 80.0

Adverse Events

Sunitinib Malate and Hepatic Artery Embolizations

Serious events: 3 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sunitinib Malate and Hepatic Artery Embolizations n=39 participants at risk Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
Gastrointestinal disorders Hemorrhage, GI - Recturm - possibly related	2.6% 1/39 • Number of events 1 • 4 years
Gastrointestinal disorders Nausea and Vomiting - unrelated	2.6% 1/39 • Number of events 2 • 4 years
Gastrointestinal disorders Dysphagia - unrelated	2.6% 1/39 • Number of events 1 • 4 years
Gastrointestinal disorders Anorexia - unrelated	2.6% 1/39 • Number of events 1 • 4 years
Gastrointestinal disorders Obstruction, GI - Gallbladder - unrelated	2.6% 1/39 • Number of events 1 • 4 years
Gastrointestinal disorders Obstruction, GI - Small bowel - unrelated	2.6% 1/39 • Number of events 1 • 4 years

Other adverse events

Other adverse events
Measure	Sunitinib Malate and Hepatic Artery Embolizations n=39 participants at risk Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
Blood and lymphatic system disorders Hemoglobin	56.4% 22/39 • 4 years
Blood and lymphatic system disorders Neutrophils/granulocytes	48.7% 19/39 • 4 years
Blood and lymphatic system disorders Platelets	35.9% 14/39 • 4 years
Gastrointestinal disorders Abdominal pain	46.2% 18/39 • 4 years
Gastrointestinal disorders Anorexia	28.2% 11/39 • 4 years
Musculoskeletal and connective tissue disorders Arthralgia	17.9% 7/39 • 4 years
General disorders Back pain	7.7% 3/39 • 4 years
Gastrointestinal disorders Constipation	15.4% 6/39 • 4 years
Respiratory, thoracic and mediastinal disorders Cough	10.3% 4/39 • 4 years
Gastrointestinal disorders Dehydration	7.7% 3/39 • 4 years
Skin and subcutaneous tissue disorders Dermatological	5.1% 2/39 • 4 years
Gastrointestinal disorders Diarrhea	20.5% 8/39 • 4 years
Skin and subcutaneous tissue disorders Dry skin	5.1% 2/39 • 4 years
Respiratory, thoracic and mediastinal disorders Dyspnea	7.7% 3/39 • 4 years
Blood and lymphatic system disorders Edema	28.2% 11/39 • 4 years
General disorders Epistaxis	5.1% 2/39 • 4 years
General disorders Fatigue	61.5% 24/39 • 4 years
General disorders Fever	30.8% 12/39 • 4 years
Skin and subcutaneous tissue disorders Hair loss	12.8% 5/39 • 4 years
General disorders Headache	17.9% 7/39 • 4 years
Gastrointestinal disorders Hemorrhoids	5.1% 2/39 • 4 years
Skin and subcutaneous tissue disorders Hyperpigmentation	10.3% 4/39 • 4 years
Cardiac disorders Hypertension	23.1% 9/39 • 4 years
General disorders Mood alterations	5.1% 2/39 • 4 years
Gastrointestinal disorders Mucositis/stomatitis	15.4% 6/39 • 4 years
Gastrointestinal disorders Nausea	35.9% 14/39 • 4 years
Nervous system disorders Neuropathy	7.7% 3/39 • 4 years
Metabolism and nutrition disorders Potassium	10.3% 4/39 • 4 years
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia	48.7% 19/39 • 4 years
Respiratory, thoracic and mediastinal disorders Pulmonary	5.1% 2/39 • 4 years
General disorders Rhinitis	7.7% 3/39 • 4 years
Gastrointestinal disorders Taste alterations	35.9% 14/39 • 4 years
Metabolism and nutrition disorders Weitht loss	5.1% 2/39 • 4 years
Gastrointestinal disorders Vomiting	25.6% 10/39 • 4 years

Additional Information

Jonathan Strosberg, M.D.

H. Lee Moffitt Cancer Center and Research Institute

Phone: 813-745-7257

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place