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Phase II Study of Sunitinib Malate Following Hepatic Artery Embolization

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ClinicalTrials.gov Identifier: NCT00434109
Recruitment Status : Completed
First Posted : February 12, 2007
Results First Posted : September 7, 2012
Last Update Posted : September 14, 2012
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Neuroendocrine Tumor
Islet Cell Tumor
Interventions Drug: Sunitinib malate
Procedure: Hepatic Artery Embolizations
Enrollment 39
Recruitment Details All patients seen at Moffitt Cancer Center with hepatic metastases from gastrointestinal neuroendocrine tumors were screened for eligibility to be enrolled in the study.
Pre-assignment Details  
Arm/Group Title Sunitinib Malate and Hepatic Artery Embolizations
Hide Arm/Group Description Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
Period Title: Overall Study
Started 39
Completed 21 [1]
Not Completed 18
Reason Not Completed
Physician Decision             9
Adverse Event             5
Protocol Violation             1
had embolism, did not receive sunitinib             3
[1]
Patients completing the maximum eight cycles of sunitinib.
Arm/Group Title Sunitinib Malate and Hepatic Artery Embolizations
Hide Arm/Group Description Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
Overall Number of Baseline Participants 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
<=18 years
0
   0.0%
Between 18 and 65 years
29
  74.4%
>=65 years
10
  25.6%
Age, Customized  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 39 participants
61
(40 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
Female
21
  53.8%
Male
18
  46.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 39 participants
39
1.Primary Outcome
Title Percentage of Participants With Progression Free Survival (PFS) at 12 Months
Hide 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.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Sunitinib Malate and Hepatic Artery Embolizations
Hide Arm/Group Description:
Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
Overall Number of Participants Analyzed 39
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
66
(51 to 81)
2.Secondary Outcome
Title Percentage of Participants With Overall Survival (OS) at One Year
Hide Description 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.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Sunitinib Malate and Hepatic Artery Embolizations
Hide Arm/Group Description:
Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
Overall Number of Participants Analyzed 39
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
95
(88 to 100)
3.Secondary Outcome
Title Number of Participants With Partial Radiographic Response
Hide Description 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.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All Participants
Arm/Group Title Sunitinib Malate and Hepatic Artery Embolizations
Hide Arm/Group Description:
Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
Overall Number of Participants Analyzed 39
Measure Type: Number
Unit of Measure: participants
28
4.Secondary Outcome
Title Number of Participants With Biochemical Response
Hide Description Biochemical response rate (>50% reduction in tumor marker). Response and progression endpoints refer specifically to hepatic metastases.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All Participants
Arm/Group Title Sunitinib Malate and Hepatic Artery Embolizations
Hide Arm/Group Description:
Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
Overall Number of Participants Analyzed 39
Measure Type: Number
Unit of Measure: participants
19
5.Secondary Outcome
Title Number of Participants Requiring Dose Reduction
Hide Description Treatment related toxicity. Participants requiring dose reductions of sunitinib to 25 mg due to side effects.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Sunitinib Malate and Hepatic Artery Embolizations
Hide Arm/Group Description:
Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
Overall Number of Participants Analyzed 39
Measure Type: Number
Unit of Measure: participants
16
6.Secondary Outcome
Title Percentage of Participants With Overall Survival (OS) at 4 Years
Hide Description 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.
Time Frame 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
All Participants
Arm/Group Title Sunitinib Malate and Hepatic Artery Embolizations
Hide Arm/Group Description:
Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
Overall Number of Participants Analyzed 39
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
59
(38 to 80)
Time Frame 4 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sunitinib Malate and Hepatic Artery Embolizations
Hide Arm/Group Description Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
All-Cause Mortality
Sunitinib Malate and Hepatic Artery Embolizations
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sunitinib Malate and Hepatic Artery Embolizations
Affected / at Risk (%) # Events
Total   3/39 (7.69%)    
Gastrointestinal disorders   
Hemorrhage, GI - Recturm - possibly related  1  1/39 (2.56%)  1
Nausea and Vomiting - unrelated  1  1/39 (2.56%)  2
Dysphagia - unrelated  1  1/39 (2.56%)  1
Anorexia - unrelated  1  1/39 (2.56%)  1
Obstruction, GI - Gallbladder - unrelated  1  1/39 (2.56%)  1
Obstruction, GI - Small bowel - unrelated  1  1/39 (2.56%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC V3
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sunitinib Malate and Hepatic Artery Embolizations
Affected / at Risk (%) # Events
Total   38/39 (97.44%)    
Blood and lymphatic system disorders   
Hemoglobin  1  22/39 (56.41%) 
Neutrophils/granulocytes  1  19/39 (48.72%) 
Platelets  1  14/39 (35.90%) 
Edema  1  11/39 (28.21%) 
Cardiac disorders   
Hypertension  1  9/39 (23.08%) 
Gastrointestinal disorders   
Abdominal pain  1  18/39 (46.15%) 
Anorexia  1  11/39 (28.21%) 
Constipation  1  6/39 (15.38%) 
Dehydration  1  3/39 (7.69%) 
Diarrhea  1  8/39 (20.51%) 
Hemorrhoids  1  2/39 (5.13%) 
Mucositis/stomatitis  1  6/39 (15.38%) 
Nausea  1  14/39 (35.90%) 
Taste alterations  1  14/39 (35.90%) 
Vomiting  1  10/39 (25.64%) 
General disorders   
Back pain  1  3/39 (7.69%) 
Epistaxis  1  2/39 (5.13%) 
Fatigue  1  24/39 (61.54%) 
Fever  1  12/39 (30.77%) 
Headache  1  7/39 (17.95%) 
Mood alterations  1  2/39 (5.13%) 
Rhinitis  1  3/39 (7.69%) 
Metabolism and nutrition disorders   
Potassium  1  4/39 (10.26%) 
Weitht loss  1  2/39 (5.13%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  7/39 (17.95%) 
Nervous system disorders   
Neuropathy  1  3/39 (7.69%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  4/39 (10.26%) 
Dyspnea  1  3/39 (7.69%) 
Pulmonary  1  2/39 (5.13%) 
Skin and subcutaneous tissue disorders   
Dermatological  1  2/39 (5.13%) 
Dry skin  1  2/39 (5.13%) 
Hair loss  1  5/39 (12.82%) 
Hyperpigmentation  1  4/39 (10.26%) 
Palmar-plantar erythrodysesthesia  1  19/39 (48.72%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC V3
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Jonathan Strosberg, M.D.
Organization: H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-7257
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00434109     History of Changes
Other Study ID Numbers: MCC-14888
GA6181079 ( Other Identifier: Pfizer )
First Submitted: February 9, 2007
First Posted: February 12, 2007
Results First Submitted: August 8, 2012
Results First Posted: September 7, 2012
Last Update Posted: September 14, 2012