Phase II Study of Sunitinib Malate Following Hepatic Artery Embolization
2 other identifiers
interventional
39
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2006
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 9, 2007
CompletedFirst Posted
Study publicly available on registry
February 12, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedResults Posted
Study results publicly available
September 7, 2012
CompletedSeptember 14, 2012
July 1, 2012
5.3 years
February 9, 2007
August 8, 2012
September 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Percentage of Participants With Overall Survival (OS) at One Year
12 months
Number of Participants With Partial Radiographic Response
12 months
Number of Participants With Biochemical Response
12 months
Number of Participants Requiring Dose Reduction
12 months
Percentage of Participants With Overall Survival (OS) at 4 Years
48 months
Study Arms (1)
Sunitinib Malate and Hepatic Artery Embolizations
EXPERIMENTALSunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
Interventions
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 necessary) will be scheduled during scheduled Sutent treatment breaks. No fewer than seven days shall separate treatment with Sutent and scheduling of 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.
Eligibility Criteria
You may qualify if:
- 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:
- Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase \[SGOT\]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase \[SGPT\]) less than or equal to 2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy
- Total serum bilirubin less than or equal to 1.5 x ULN
- Absolute neutrophil count (ANC) greater than or equal to 1500/microL
- Platelets greater than or equal to 100,000/microL
- Hemoglobin greater than or equal to 9.0 g/dL
- Serum calcium less than or equal to 12.0 mg/dL
- Serum creatinine less than or equal to 1.5 x ULN
- Prothrombin and activated partial thromboplastin time (PT and aPTT) less than or equal to 1.5 x ULN
- 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.
You may not qualify if:
- 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).
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lee Moffitt Cancer Center and Research Institutelead
- Pfizercollaborator
Study Sites (1)
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jonathan Strosberg, M.D.
- Organization
- H. Lee Moffitt Cancer Center and Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Strosberg, MD
H. Lee Moffitt Cancer Center and Research Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2007
First Posted
February 12, 2007
Study Start
November 1, 2006
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
September 14, 2012
Results First Posted
September 7, 2012
Record last verified: 2012-07