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Phase II Study of Sunitinib Malate Following Hepatic Artery Embolization

Information source: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neuroendocrine Tumor; Islet Cell Tumor

Intervention: Sunitinib malate (Drug); Hepatic Artery Embolizations (Procedure)

Phase: Phase 2

Status: Completed

Sponsored by: H. Lee Moffitt Cancer Center and Research Institute

Official(s) and/or principal investigator(s):
Jonathan Strosberg, MD, Principal Investigator, Affiliation: H. Lee Moffitt Cancer Center and Research Institute

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.

Clinical Details

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

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

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

Secondary outcome:

Percentage of Participants With Overall Survival (OS) at One Year

Number of Participants With Partial Radiographic Response

Number of Participants With Biochemical Response

Number of Participants Requiring Dose Reduction

Percentage of Participants With Overall Survival (OS) at 4 Years

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 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.

Locations and Contacts

H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida 33612, United States
Additional Information

Moffitt Cancer Center Clinical Trials Website

Starting date: November 2006
Last updated: September 7, 2012

Page last updated: August 23, 2015

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