- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00113516
A Study Of SU011248 As Therapy In Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer
May 14, 2010 updated by: Pfizer
Phase 2 Study Of SU011248 As Consolidation Therapy In Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
84
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V5Z4E6
- Pfizer Investigational Site
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Quebec
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Montreal, Quebec, Canada, H2L 4M1
- Pfizer Investigational Site
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Caen Cedex 05, France, 14076
- Pfizer Investigational Site
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Villejuif, France, 94805
- Pfizer Investigational Site
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California
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Los Angeles, California, United States, 90048
- Pfizer Investigational Site
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Delaware
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Newark, Delaware, United States, 19718
- Pfizer Investigational Site
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Newark, Delaware, United States, 19713
- Pfizer Investigational Site
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Wilmington, Delaware, United States, 19899
- Pfizer Investigational Site
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Illinois
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Maywood, Illinois, United States, 60153
- Pfizer Investigational Site
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Indiana
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Jeffersonville, Indiana, United States, 47130
- Pfizer Investigational Site
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Kentucky
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Louisville, Kentucky, United States, 40202
- Pfizer Investigational Site
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Louisville, Kentucky, United States, 40217
- Pfizer Investigational Site
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Louisville, Kentucky, United States, 40241
- Pfizer Investigational Site
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Shelbyville, Kentucky, United States, 40065
- Pfizer Investigational Site
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Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Pfizer Investigational Site
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Tennessee
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Franklin, Tennessee, United States, 37067
- Pfizer Investigational Site
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Gallatin, Tennessee, United States, 37066
- Pfizer Investigational Site
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Hermitage, Tennessee, United States, 37076
- Pfizer Investigational Site
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Lebanon, Tennessee, United States, 37087
- Pfizer Investigational Site
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Murfreesboro, Tennessee, United States, 37130
- Pfizer Investigational Site
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Nashville, Tennessee, United States, 37203
- Pfizer Investigational Site
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Nashville, Tennessee, United States, 37205
- Pfizer Investigational Site
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Nashville, Tennessee, United States, 37207
- Pfizer Investigational Site
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Nashville, Tennessee, United States, 37211
- Pfizer Investigational Site
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Nashville, Tennessee, United States, 37203-1632
- Pfizer Investigational Site
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Smyrna, Tennessee, United States, 37167
- Pfizer Investigational Site
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Texas
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Burleson, Texas, United States, 76028
- Pfizer Investigational Site
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Cleburne, Texas, United States, 76031
- Pfizer Investigational Site
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Fort Worth, Texas, United States, 76104
- Pfizer Investigational Site
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Mineral Wells, Texas, United States, 76067
- Pfizer Investigational Site
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Weatherford, Texas, United States, 76086
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
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AUC of 6 mg*min/mL via IV infusion every 21 days for 4 cycles as per institutional practices.
Other Names:
175-225 mg/m2 via IV infusion every 21 days for 4 cycles as per institutional practices.
Other Names:
50 mg orally daily for 4 weeks followed by 2 weeks off treatment up to 1 year (after completing 1 year of treatment, pts deriving clinical benefit may continue to receive sunitinib in a separate continuation protocol).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Proportion of Subjects Surviving at One Year
Time Frame: From start of treatment until 1 year or death
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Proportion of those surviving at the end of one year from the first dose of study treatment.
In the absence of confirmation of death, survival time was censored at the last date the subject was known to be alive.
Patients lacking data beyond the day of first dose had their survival time censored at Day 1 of treatment.
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From start of treatment until 1 year or death
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Progression-free Survival (PFS)
Time Frame: 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
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PFS was defined as the time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first.
If tumor progression data included more than 1 date, the first date was used.
PFS (in weeks) was calculated as (first event date - first paclitaxel/carboplatin dose date +1)/7.02.
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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
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Time to Tumor Progression (TTP)
Time Frame: 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)
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TTP was defined as the time from start of study treatment to first documentation of objective disease progression.
If tumor progression data included more than 1 date, the first date was used.
TTP (in weeks) was calculated as (first event date - first paclitaxel/carboplatin dose date +1)/7.02.
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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)
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Duration of Response (DR)
Time Frame: 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
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DR=time from the first documentation of objective tumor response (complete response [CR] or partial response [PR]) that was subsequently confirmed to first documentation of objective disease progression or death due to any cause, whichever was first.
CR=disappearance of all target lesions.
PR=a > = 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions.
If tumor progression data included more than 1 date, first date was used.
DR (in weeks) was calculated as (the end date for DR - first CR or PR that was subsequently confirmed +1)/7.02.
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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
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Number of Subjects With Overall Confirmed Objective Disease Response
Time Frame: 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)
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Objective disease response = subjects with confirmed CR or PR according to the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.0).
A CR was defined as the disappearance of all target lesions.
A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
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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)
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Overall Survival (OS)
Time Frame: From start of study treatment until death
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OS was defined as the time from start of study treatment to death due to any cause.
OS (in months) was calculated as (date of death - date of paclitaxel/carboplatin first dose +1)/30.4.
For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive.
Subjects lacking data beyond the day of first dose of paclitaxel/carboplatin had their survival time censored at Day 1 of paclitaxel/carboplatin treatment.
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From start of study treatment until death
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Trough Plasma Concentration (Ctrough) of Sunitinib
Time Frame: predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
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Ctrough = the plasma concentration prior to study drug administration.
On Day 28, this parameter provided and idea of the concentration at steady state since no big fluctuation was expected in a 24 hour interval.
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predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
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Ctrough of SU-012662 (Sunitinib's Metabolite)
Time Frame: predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
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Ctrough = the plasma concentration prior to study drug administration.
On Day 28, this parameter provided and idea of the concentration at steady state since no big fluctuation was expected in a 24 hour interval.
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predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
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Ctrough of Total Drug (Sunitinib + SU-012662)
Time Frame: predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
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Ctrough = the plasma concentration prior to study drug administration.
On Day 28, this parameter provided and idea of the concentration at steady state since no big fluctuation was expected in a 24 hour interval.
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predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
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Dose-Corrected Ctrough of Sunitinib
Time Frame: predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
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Ctrough = the plasma concentration prior to study drug administration.
Dose correction was made to the initial intended dose in Cycle 1.
This was determined due to potential dose changes throughout the study in different subjects.
It was calculated as the observed values multiplied by the reference dose (50 mg) divided by the actual dose.
For dose-corrected trough concentration, only trough concentration values from subjects who received sunitinib during at least the last 10 consecutive days of dosing at the same dose level were included.
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predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
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Dose-Corrected Ctrough of SU-012662 (Sunitinib's Metabolite)
Time Frame: predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
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Ctrough = the plasma concentration prior to study drug administration.
Dose correction was made to the initial intended dose in Cycle 1.
This was determined due to potential dose changes throughout the study in different subjects.
It was calculated as the observed values multiplied by the reference dose (50 mg) divided by the actual dose.
For dose-corrected trough concentration, only trough concentration values from subjects who received sunitinib during at least the last 10 consecutive days of dosing at the same dose level were included.
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predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
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Dose-Corrected Ctrough of Total Drug (Sunitinib + SU-012662)
Time Frame: predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
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Ctrough = the plasma concentration prior to study drug administration.
Dose correction was made to the initial intended dose in Cycle 1.
This was determined due to potential dose changes throughout the study in different subjects.
It was calculated as the observed values multiplied by the reference dose (50 mg) divided by the actual dose.
For dose-corrected trough concentration, only trough concentration values from subjects who received sunitinib during at least the last 10 consecutive days of dosing at the same dose level were included.
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predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
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Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Concentration at Baseline
Time Frame: Baseline (Cycle 1, Day 1) of Part 2
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Concentration of VEGFR3 at baseline.
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Baseline (Cycle 1, Day 1) of Part 2
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VEGFR3 Ratio to Baseline at Each Time Point
Time Frame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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VEGFR3 concentration at each time point divided by VEGFR3 concentration at baseline (ratio to baseline).
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Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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VEGF-C Concentration at Baseline
Time Frame: Baseline (Cycle 1, Day 1) of Part 2
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Concentration of VEGF-C at baseline.
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Baseline (Cycle 1, Day 1) of Part 2
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VEGF-C Ratio to Baseline at Each Time Point
Time Frame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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VEGF-C concentration at each time point divided by VEGF-C concentration at baseline (ratio to baseline).
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Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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Soluble E-Selectin at Baseline
Time Frame: Baseline (Cycle 1, Day 1) of Part 2
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Concentration of soluble E-Selectin at baseline.
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Baseline (Cycle 1, Day 1) of Part 2
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Soluble E-Selectin Ratio to Baseline at Each Time Point
Time Frame: 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
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Soluble E-Selectin concentration at each time point divided by soluble E-Selectin concentration at baseline (ratio to baseline).
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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
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VEGFR3 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)
Time Frame: Baseline (Cycle 1, Day 1) of Part 2
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Median concentration of VEGFR3 at baseline stratified by tumor response (CR or PR or [SD > = 6 Weeks] or PD).
A measure of dispersion is not included because the Wilcoxon rank sum test is a nonparametric test that makes no assumptions about the distribution of the data (eg, normality).
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Baseline (Cycle 1, Day 1) of Part 2
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VEGFR3 Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)
Time Frame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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Median VEGFR3 concentration at each time point divided by median VEGFR3 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 6 weeks] or PD).
A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
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Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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VEGF-C at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)
Time Frame: Baseline (Cycle 1, Day 1) of Part 2
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Median concentration of VEGF-C at baseline stratified by tumor response (CR or PR or [SD > = 6 Weeks] or PD).
A measure of dispersion is not included because the Wilcoxon rank sum test is a nonparametric test that makes no assumptions about the distribution of the data (eg, normality).
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Baseline (Cycle 1, Day 1) of Part 2
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VEGF-C Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)
Time Frame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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Median VEGF-C concentration at each time point divided by median VEGF-C concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 6 weeks] or PD).
A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
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Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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Soluble E-Selectin at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)
Time Frame: Baseline (Cycle 1, Day 1) of Part 2
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Median concentration of soluble E-selectin at baseline stratified by tumor response (CR or PR or [SD > = 6 Weeks] or PD).
A measure of dispersion is not included because the Wilcoxon rank sum test is a nonparametric test that makes no assumptions about the distribution of the data (eg, normality).
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Baseline (Cycle 1, Day 1) of Part 2
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Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)
Time Frame: 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
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Median soluble E-selectin concentration at each time point divided by median soluble E-selectin concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or [SD > = 6 weeks] or PD).
A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).
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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
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Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline
Time Frame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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PFS = time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first.
If tumor progression data included more than 1 date, the first date was used.
PFS (in weeks) was calculated as (first event date minus first sunitinib dose date +1)divided by 7.02.
Groups are defined by < or > = median levels of VEGFR3 at Baseline and after Stratification by < or > = median changes from Baseline in VEGFR3 at each time point.
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Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline
Time Frame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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PFS = time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first.
If tumor progression data included more than 1 date, the first date was used.
PFS (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02.
Groups are defined by < or > = median levels of VEGF-C at Baseline and after stratification by < or > = median changes from Baseline in VEGF-C at each time point.
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Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline
Time Frame: [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
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PFS = time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first.
If tumor progression data included more than 1 date, the first date was used.
PFS (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02.
Groups are defined by < or > = median levels of soluble E-selectin at Baseline and after stratification by < or > = median changes from Baseline in soluble E-selectin at each time point.
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[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
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Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline
Time Frame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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TTP = time from start of study treatment to first documentation of objective disease progression.
If tumor progression data included more than 1 date, the first date was used.
TTP (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02.
Groups are defined by < or > = median levels of VEGFR3 at Baseline and after stratification by < or > = median changes from baseline in VEGFR3 at each time point.
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Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline
Time Frame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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TTP = time from start of study treatment to first documentation of objective disease progression.
If tumor progression data included more than 1 date, the first date was used.
TTP (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02.
Groups are defined by < or > = median levels of VEGF-C at Baseline and after stratification by < or > = median changes from Baseline in VEGF-C at each time point.
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Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline Changes From Baseline
Time Frame: 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
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TTP = time from start of study treatment to first documentation of objective disease progression.
If tumor progression data included more than 1 date, the first date was used.
TTP (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02.
Groups are defined by < or > = median levels of soluble E-selectin at Baseline and after stratification by < or > = median changes from Baseline in soluble E-selectin at each time point.
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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
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Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline
Time Frame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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OS = time from start of study treatment to death due to any cause.
OS (in months) was calculated as (date of death minus date of sunitinib first dose +1)divided by 30.4.
For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive.
Subjects lacking data beyond the day of first dose of sunitinib had their survival time censored at Day 1 of sunitinib treatment.
Groups are defined by < or > = median levels of VEGFR3 at Baseline and after stratification by < or > = median changes from Baseline in VEGFR3 at each time point.
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Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline
Time Frame: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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OS = time from start of study treatment to death due to any cause.
OS (in months) was calculated as (date of death minus date of sunitinib first dose +1) divided by 30.4.
For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive.
Subjects lacking data beyond the day of first dose of sunitinib had their survival time censored at Day 1 of sunitinib treatment.
Groups are defined by < or > = median levels of VEGF-C at Baseline and after stratification by < or > = median changes from Baseline in VEGF-C at each time point.
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Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline
Time Frame: 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
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OS=time from start of study treatment to death due to any cause.
OS (in months) calculated as (date of death minus date of sunitinib first dose +1) divided by 30.4.
For subjects not expiring their survival times were censored at last date of known contact they were known to be alive.
Subjects lacking data beyond day of first dose of sunitinib had their survival time censored at Day 1 of sunitinib treatment.
Groups are defined by < or > = median levels of soluble E-selectin at Baseline and after stratification by < or > = median changes from Baseline in soluble E-selectin at each time point.
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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
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Immunohistochemical Staining of Paraffin Embedded Tumor Tissue
Time Frame: Screening
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Previously collected tumor paraffin block (or 12-20 10-micron slides prepared for the paraffin block) for correlative laboratory analysis.
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Screening
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Correlation of Polymorphisms in c-Kit, Flt-3 and c-Fms to Safety of Sunitinib
Time Frame: Within 7 days of Day 1
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A blood sample (6 mL) was collected and used to isolate DNA.
These samples were not anonymized.
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Within 7 days of Day 1
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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)
Time Frame: Baseline (Part 1) to Cycle1 (Days 1 [baseline], 28), Cycles 2 and 3 (Days 1, 28), and Cycle 4 (Day 1) in Part 2
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EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea).
Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent.
Scale score range: 0 to 100.
Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
Change: score at each visit in Part 2 minus baseline score in Part 1.
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Baseline (Part 1) to Cycle1 (Days 1 [baseline], 28), Cycles 2 and 3 (Days 1, 28), and Cycle 4 (Day 1) in Part 2
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Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13)
Time Frame: Baseline (Part 1) to Cycle1 (Days 1 [baseline], 28), Cycles 2 and 3 (Days 1, 28), and Cycle 4 (Day 1) in Part 2
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QLQ-LC13 assessed lung cancer symptoms (dyspnea, coughing, dysphasia, hemoptysis, sore mouth, peripheral neuropathy, alopecia, chest pain, arm pain, shoulder pain, and pain in other parts).
Recall period: past week; response range: not at all to very much.
Scale score range: 0 to 100.
Higher symptom score = greater degree of symptoms.
Change: score at each visit in Part 2 minus baseline score in Part 1.
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Baseline (Part 1) to Cycle1 (Days 1 [baseline], 28), Cycles 2 and 3 (Days 1, 28), and Cycle 4 (Day 1) in Part 2
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
June 8, 2005
First Submitted That Met QC Criteria
June 8, 2005
First Posted (Estimate)
June 9, 2005
Study Record Updates
Last Update Posted (Estimate)
May 18, 2010
Last Update Submitted That Met QC Criteria
May 14, 2010
Last Verified
May 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Carboplatin
- Paclitaxel
- Sunitinib
Other Study ID Numbers
- A6181057
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.