Clinical trial NCT00372775: Study Tests The Safety And Effectiveness Of SU011248 In Patients With Non-Small Cell Lung Cancer Having Brain Metastases
Official title: A Phase 2 Efficacy And Safety Study Of SU011248 In Patients With Non-Small Cell Lung Cancer And Brain Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: brain metastases
Sunitinib
Phase 2
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-09-07
Enrollment: 66
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: This study will evaluate the safety, tolerability and efficacy of SU011248 in patients with non-small cell lung cancer with brain metastases.


Eligibility criteria: Inclusion Criteria:

* Patients with radiologically proven brain metastases secondary to non-small cell lung cancer
* Received previous whole brain radiation therapy and none, 1 or 2 prior systemic therapy for the treatment of advanced/metastatic non-small cell lung cancer

Exclusion Criteria:

* Patients with brainstem lesions, spinal cord compression. carcinomatous meningitis, or leptomeningeal disease.
* Brain metastases \>4 cm in any linear direction
* Intracranial or intratumoral hemorrhage

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to tumor progression or death (up to 1 year)
Secondary outcomes:
measure: Time to Tumor Progression (TTP)
timeFrame: Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to tumor progression (up to 1 year)
measure: Time to Neurological Progression (TNP)
timeFrame: Baseline, Day 28 to focal neurological deficit (up to 1 year)
measure: Number of Participants With Objective Disease Response
timeFrame: Baseline and Day 1 of Week 5, 9, 17, 25, 33, 41, and 49
measure: Time to Objective Intracranial Progression
timeFrame: Baseline, Day 1 of Week 5, 9, 17, 25, 33, and 41 to intracranial tumor progression (up to 1 year)
measure: Number of Participants With Intracranial Objective Disease Response
timeFrame: Baseline and Day 1 of Week 5, 9, 17, 25, 33, 41, and 49
measure: Duration of Response (DR)
timeFrame: Day 7 of Week 4 and every 4 weeks up to 1 year
measure: Overall Survival (OS)
timeFrame: Baseline until death (up to 1 year)
measure: Percentage of Participants Surviving at 1 Year
timeFrame: Year 1
measure: Number of Deaths Due to Intracranial Versus Systemic Progression
timeFrame: Baseline until death (up to 1 year)
measure: Change From Baseline in Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network (FACT/NCCN) Lung Symptom Index (FLSI) Score
timeFrame: Baseline, Day 1 of Week 5 and every 4 weeks to end of treatment (up to 1 year)
measure: Change From Baseline in FACT/NCCN Brain Symptom Index (FBrSI) Score
timeFrame: Baseline, Day 1 of Week 5 and every 4 weeks to end of treatment (up to 1 year)
measure: Trough Plasma Concentrations (Ctrough) of Sunitinib
timeFrame: Day 1 of Week 5, 9, and 13
measure: Ctrough of Sunitinib Metabolite (SU012662)
timeFrame: Day 1 of Week 5, 9, and 13
measure: Correlation of Polymorphisms in c-Kit, Flt-3 and c-Fms With Blood Counts
timeFrame: Day 1 prior to dosing
measure: Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile
timeFrame: Day 1 of Week 1 and every 4 weeks up to 1 year
measure: PFS in Subgroups Defined by RNA Expression Profiles of Tumors
timeFrame: Day 1 of Week 1 and every 4 weeks up to 1 year
Other outcomes:
Locations:
city: Norwalk
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Cocoa Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Merritt Island
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Titusville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Creve Coeur
country: United States
facility: Pfizer Investigational Site
state: Missouri
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: St. Peters
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Basking Ridge
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Commack
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Sayre
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Round Rock
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Pessac
country: France
facility: Pfizer Investigational Site
state: Be1 04495
city: Marseille Cedex 09
country: France
facility: Pfizer Investigational Site
city: Saint-Priest en Jarez Cedex
country: France
facility: Pfizer Investigational Site
city: Toulouse cedex 9
country: France
facility: Pfizer Investigational Site
city: Bologna
country: Italy
facility: Pfizer Investigational Site
city: Genova
country: Italy
facility: Pfizer Investigational Site
city: Orbassano (TO)
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: