Phase II Study Of Sunitinib Malate Following Hepatic Artery Embolization

Study Overview

Phase II Study of Sunitinib Malate Following Hepatic Artery Embolization

The purpose of this study is to decide if a medicine that slows growth of new blood vessels can be give after the embolization procedure to prevent or delay new growth of blood vessels to tumors.

This is a single-center, open-label, non-randomized, prospective phase II trial. Sutent treatment will be continued until disease progression, or excessive toxicity (as determined by treating physician or primary investigator), or until a maximum of eight cycles, whichever duration is shorter.

Neuroendocrine Tumor
Islet Cell Tumor

DRUG: Sunitinib malate
PROCEDURE: Hepatic Artery Embolizations

MCC-14888
GA6181079 (OTHER Identifier) (OTHER: Pfizer)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2007-02-09	Results First Submitted 2012-08-08	Last Update Submitted that met QC Criteria 2012-09-07
First Submitted that Met QC Criteria 2007-02-09	Results First Submitted that Met QC Criteria 2012-08-08	Last Update Posted (ESTIMATED) 2012-09-14
First Posted (ESTIMATED) 2007-02-12	Results First Posted 2012-09-07	Last Verified 2012-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 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.	DRUG: Sunitinib malate Sunitinib malate (Sutent) at a dose of 37.5mg will be administered orally once daily on days 1-28 in a 42-day cycle. Treatment with Sutent will begin no sooner than seven days after the first hepatic artery embolization. Subsequent embolizations (if neces PROCEDURE: Hepatic Artery Embolizations 1-3 selective hepatic artery embolizations will be performed at approximately 5-week intervals, based on the extent of hepatic involvement with tumor.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 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.

DRUG: Sunitinib malate

Sunitinib malate (Sutent) at a dose of 37.5mg will be administered orally once daily on days 1-28 in a 42-day cycle. Treatment with Sutent will begin no sooner than seven days after the first hepatic artery embolization. Subsequent embolizations (if neces

PROCEDURE: Hepatic Artery Embolizations

1-3 selective hepatic artery embolizations will be performed at approximately 5-week intervals, based on the extent of hepatic involvement with tumor.

Primary Outcome Measures	Measure Description	Time Frame
Percentage of Participants With Progression Free Survival (PFS) at 12 Months	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.	12 months

Secondary Outcome Measures	Measure Description	Time Frame
Percentage of Participants With Overall Survival (OS) at One Year	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.	12 months
Number of Participants With Partial Radiographic Response	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.	12 months
Number of Participants With Biochemical Response	Biochemical response rate (>50% reduction in tumor marker). Response and progression endpoints refer specifically to hepatic metastases.	12 months
Number of Participants Requiring Dose Reduction	Treatment related toxicity. Participants requiring dose reductions of sunitinib to 25 mg due to side effects.	12 months
Percentage of Participants With Overall Survival (OS) at 4 Years	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.	48 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Well-differentiated metastatic carcinoid tumors and pancreatic endocrine tumors with measurable liver metastases.
Resolution of all acute toxic effects of prior chemotherapy or radiotherapy or surgical procedures to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0 grade less than or equal to 1.
Adequate organ function as defined by the following criteria:

Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2
Informed Consent: Patients must be aware of the nature of his/her disease process and must willingly give consent after being informed of the experimental nature of therapy, alternatives, potential benefits, side-effects, risks and discomforts.

Major surgery or radiation therapy within 4 weeks of starting the study treatment.
Prior hepatic artery embolization or chemoembolization.
Prior treatment with a tyrosine kinase inhibitor or a vascular endothelial growth factor (VEGF) inhibitor.
NCI CTCAE grade 3 hemorrhage within 4 weeks of starting the study treatment.
History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening computed tomography (CT) or magnetic Resonance imaging (MRI) scan.
Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
Ongoing cardiac dysrhythmias of NCI CTCAE grade greater than or equal to 2.
Prolonged corrected QT (QTc) interval on baseline electrocardiogram (EKG).
Hypertension that cannot be controlled by medications (>150/100 mm Hg despite optimal medical therapy).
Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication.
Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness or other active infection
Concurrent treatment on another clinical trial. Supportive care trials or non-treatment trials, e.g. Quality of Life (QOL), are allowed.
Concomitant use of ketoconazole and other agents known to induce CYP3A4.
Concomitant use of theophylline and phenobarbital and/or other agents metabolized by the cytochrome P450 system.
Ongoing treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg by mouth (po) daily for thrombo prophylaxis is allowed).
Pregnancy or breastfeeding. Female participants must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. Female participants with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment. Male participants must be surgically sterile or must agree to use effective contraception during the period of therapy.
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Pfizer

Investigators

PRINCIPAL_INVESTIGATOR: Jonathan Strosberg, MD, H. Lee Moffitt Cancer Center and Research Institute

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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