Phase II Study of Sunitinib Malate Following Hepatic Artery Embolization

NCT00434109

Last updated date
Study Location
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neuroendocrine Tumor, Islet Cell Tumor
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Neuroendocrine Tumor, Islet Cell TumorPhase II Study of Sunitinib Malate Following Hepatic Artery Embolization
NCT00434109
  1. Tampa, Florida
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Phase II Study of Sunitinib Malate Following Hepatic Artery Embolization
Official Title  ICMJE Phase II Study of Sunitinib Malate Following Hepatic Artery Embolization for Metastatic Gastrointestinal Neuroendocrine Tumors
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Neuroendocrine Tumor
  • Islet Cell Tumor
Intervention  ICMJE
  • 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 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.
    Other Name: Sutent
  • 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.
Study Arms  ICMJE 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.
Interventions:
  • Drug: Sunitinib malate
  • Procedure: Hepatic Artery Embolizations
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 9, 2007)
39
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00434109
Other Study ID Numbers  ICMJE MCC-14888
GA6181079 ( Other Identifier: Pfizer )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party H. Lee Moffitt Cancer Center and Research Institute
Study Sponsor  ICMJE H. Lee Moffitt Cancer Center and Research Institute
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Jonathan Strosberg, MDH. Lee Moffitt Cancer Center and Research Institute
PRS Account H. Lee Moffitt Cancer Center and Research Institute
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP