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Phase II Study of Sunitinib Malate Following Hepatic Artery Embolization for Metastatic Gastrointestinal Neuroendocrine Tumors

Phase 2
18 Years
Not Enrolling
Neuroendocrine Tumor, Islet Cell Tumor

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Trial Information

Phase II Study of Sunitinib Malate Following Hepatic Artery Embolization for Metastatic Gastrointestinal Neuroendocrine 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.

Inclusion Criteria:

- 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:

1. 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

2. Total serum bilirubin less than or equal to 1.5 x ULN

3. Absolute neutrophil count (ANC) greater than or equal to 1500/microL

4. Platelets greater than or equal to 100,000/microL

5. Hemoglobin greater than or equal to 9.0 g/dL

6. Serum calcium less than or equal to 12.0 mg/dL

7. Serum creatinine less than or equal to 1.5 x ULN

8. 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.

Exclusion Criteria:

- 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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Participants With Progression Free Survival (PFS) at 12 Months

Outcome Description:

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.

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Jonathan Strosberg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Institutional Review Board

Study ID:




Start Date:

November 2006

Completion Date:

February 2012

Related Keywords:

  • Neuroendocrine Tumor
  • Islet Cell Tumor
  • Carcinoid
  • Pancreatic
  • Metastatic
  • Neuroendocrine
  • Tumors
  • Hepatic
  • Artery
  • Embolization
  • Angiogenesis
  • Sunitinib
  • Malate
  • Sutent
  • Tyrosine
  • Kinase
  • Inhibitor
  • Neuroendocrine Tumors
  • Adenoma, Islet Cell



H. Lee Moffitt Cancer Center & Research Institute Tampa, Florida  33612