Clinical trial NCT00113516: A Study Of SU011248 As Therapy In Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer
Official title: Phase 2 Study Of SU011248 As Consolidation Therapy In Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: Lung Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-06-09
Enrollment: 84
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: The purpose of this study is to find out if SU011248 (sunitinib) provides additional benefit when it is given after treatment with two chemotherapy drugs carboplatin and paclitaxel and also if sunitinib is safe for patients with locally advanced and metastatic Non Small Cell Lung Cancer (NSCLC).


Eligibility criteria: Inclusion Criteria:

* Histologically proven NSCLC
* Stage IIIB (locally advanced with malignant effusion) or Stage IV disease
* No prior therapy for NSCLC
* Evidence of unidimensionally measurable disease

Exclusion Criteria:

* Previous treatment with systemic chemotherapy for lung cancer
* History of or known brain metastases
* NCI CTCAE Grade 3 hemorrhage within 4 weeks of starting study treatment
* Evidence of hemoptysis within 4 weeks of starting study treatment
* Serious acute or chronic illness or recent history of significant cardiac abnormality
* Previous treatment with anti-angiogenesis agents including thalidomide, or inhibitors of EGFR and PDGFR

Primary outcomes:
measure: Proportion of Subjects Surviving at One Year
timeFrame: From start of treatment until 1 year or death
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib) or death
measure: Time to Tumor Progression (TTP)
timeFrame: From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib)
measure: Duration of Response (DR)
timeFrame: From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib) or death
measure: Number of Subjects With Overall Confirmed Objective Disease Response
timeFrame: From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib)
measure: Overall Survival (OS)
timeFrame: From start of study treatment until death
measure: Trough Plasma Concentration (Ctrough) of Sunitinib
timeFrame: predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
measure: Ctrough of SU-012662 (Sunitinib's Metabolite)
timeFrame: predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
measure: Ctrough of Total Drug (Sunitinib + SU-012662)
timeFrame: predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
measure: Dose-Corrected Ctrough of Sunitinib
timeFrame: predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
measure: Dose-Corrected Ctrough of SU-012662 (Sunitinib's Metabolite)
timeFrame: predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
measure: Dose-Corrected Ctrough of Total Drug (Sunitinib + SU-012662)
timeFrame: predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
measure: Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Concentration at Baseline
timeFrame: Baseline (Cycle 1, Day 1) of Part 2
measure: VEGFR3 Ratio to Baseline at Each Time Point
timeFrame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
measure: VEGF-C Concentration at Baseline
timeFrame: Baseline (Cycle 1, Day 1) of Part 2
measure: VEGF-C Ratio to Baseline at Each Time Point
timeFrame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
measure: Soluble E-Selectin at Baseline
timeFrame: Baseline (Cycle 1, Day 1) of Part 2
measure: Soluble E-Selectin Ratio to Baseline at Each Time Point
timeFrame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2
measure: VEGFR3 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)
timeFrame: Baseline (Cycle 1, Day 1) of Part 2
measure: VEGFR3 Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)
timeFrame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
measure: VEGF-C at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)
timeFrame: Baseline (Cycle 1, Day 1) of Part 2
measure: VEGF-C Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)
timeFrame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
measure: Soluble E-Selectin at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)
timeFrame: Baseline (Cycle 1, Day 1) of Part 2
measure: Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)
timeFrame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2
measure: Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline
timeFrame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
measure: Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline
timeFrame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
measure: Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline
timeFrame: [Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2
measure: Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline
timeFrame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
measure: Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline
timeFrame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
measure: Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline Changes From Baseline
timeFrame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2
measure: Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline
timeFrame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
measure: Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline
timeFrame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
measure: Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline
timeFrame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2
measure: Immunohistochemical Staining of Paraffin Embedded Tumor Tissue
timeFrame: Screening
measure: Correlation of Polymorphisms in c-Kit, Flt-3 and c-Fms to Safety of Sunitinib
timeFrame: Within 7 days of Day 1
measure: Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)
timeFrame: Baseline (Part 1) to Cycle1 (Days 1 [baseline], 28), Cycles 2 and 3 (Days 1, 28), and Cycle 4 (Day 1) in Part 2
measure: Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13)
timeFrame: Baseline (Part 1) to Cycle1 (Days 1 [baseline], 28), Cycles 2 and 3 (Days 1, 28), and Cycle 4 (Day 1) in Part 2
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Newark
country: United States
facility: Pfizer Investigational Site
state: Delaware
city: Newark
country: United States
facility: Pfizer Investigational Site
state: Delaware
city: Wilmington
country: United States
facility: Pfizer Investigational Site
state: Delaware
city: Maywood
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Jeffersonville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Shelbyville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Hershey
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Franklin
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Gallatin
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Hermitage
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Lebanon
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Murfreesboro
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Smyrna
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Burleson
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Cleburne
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Mineral Wells
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Weatherford
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Caen Cedex 05
country: France
facility: Pfizer Investigational Site
city: Villejuif
country: France
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: