Clinical trial NCT00056693: Treatment With SU11248 in Patients With Neuroendocrine Tumors
Official title: A Phase II Study Of The Efficacy And Safety Of SU011248 In Patients With Advanced Unresectable Neuroendocrine Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuroendocrine Tumors
Keywords: Neuroendocrine tumor, advanced disease, sunitinib, Phase 2
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2003-03-24
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the safety and efficacy of SU11248 in patients with Neuroendocrine Tumors.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically proven diagnosis of carcinoid tumor or pancreatic islet cell tumor.
* Evidence of unidimensionally measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST).
* ECOG performance status 0 or 1

Exclusion Criteria:

* Diagnosis of small-cell carcinoma, pheochromocytoma/paraganglioma, Merkel cell carcinoma, or any other second malignancy within the last 5 years except for adequately treated basal cell or squamous cell skin cancer, or for in situ carcinoma of the cervix uteri.
* Prior treatment with any tyrosine kinase inhibitors or anti-VEGF angiogenic inhibitors. Prior treatment with non-VEGF-targeted angiogenic inhibitors is permitted.

Primary outcomes:
measure: Radiographic objective disease response
timeFrame: From screening until disease progression or discontinuation of study
Secondary outcomes:
measure: To assess safety (adverse events and lab abnormalities)
timeFrame: From screening until patient death or discontinuation of study
measure: To assess patient-reported outcomes and treatment-related symptoms
timeFrame: From screening until patient death or discontinuation of study
measure: To assess pharmacokinetics and biomarkers
timeFrame: From screening until patient death or discontinuation of study
measure: To assess overall survival at 1 year
timeFrame: From screening until patient death or discontinuation of study
measure: To assess other measures of antitumor efficacy including TTP and survival
timeFrame: From screening until patient death or discontinuation of study
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: Pinckneyville
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: St Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Lamarca A, Barriuso J, Kulke M, Borbath I, Lenz HJ, Raoul JL, Meropol NJ, Lombard-Bohas C, Posey J, Faivre S, Raymond E, Valle JW. Determination of an optimal response cut-off able to predict progression-free survival in patients with well-differentiated advanced pancreatic neuroendocrine tumours treated with sunitinib: an alternative to the current RECIST-defined response. Br J Cancer. 2018 Jan;118(2):181-188. doi: 10.1038/bjc.2017.402. Epub 2017 Nov 21.
citation: Zurita AJ, Khajavi M, Wu HK, Tye L, Huang X, Kulke MH, Lenz HJ, Meropol NJ, Carley W, DePrimo SE, Lin E, Wang X, Harmon CS, Heymach JV. Circulating cytokines and monocyte subpopulations as biomarkers of outcome and biological activity in sunitinib-treated patients with advanced neuroendocrine tumours. Br J Cancer. 2015 Mar 31;112(7):1199-205. doi: 10.1038/bjc.2015.73.