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A Study Of SU011248 As Therapy In Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer

14 de mayo de 2010 actualizado por: 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).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

84

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Canadá
    • British Columbia
      • Vancouver, British Columbia, Canadá, V5Z4E6
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canadá, H2L 4M1
        • Pfizer Investigational Site
  • Estados Unidos
    • California
      • Los Angeles, California, Estados Unidos, 90048
        • Pfizer Investigational Site
    • Delaware
      • Newark, Delaware, Estados Unidos, 19718
        • Pfizer Investigational Site
      • Newark, Delaware, Estados Unidos, 19713
        • Pfizer Investigational Site
      • Wilmington, Delaware, Estados Unidos, 19899
        • Pfizer Investigational Site
    • Illinois
      • Maywood, Illinois, Estados Unidos, 60153
        • Pfizer Investigational Site
    • Indiana
      • Jeffersonville, Indiana, Estados Unidos, 47130
        • Pfizer Investigational Site
    • Kentucky
      • Louisville, Kentucky, Estados Unidos, 40202
        • Pfizer Investigational Site
      • Louisville, Kentucky, Estados Unidos, 40217
        • Pfizer Investigational Site
      • Louisville, Kentucky, Estados Unidos, 40241
        • Pfizer Investigational Site
      • Shelbyville, Kentucky, Estados Unidos, 40065
        • Pfizer Investigational Site
    • Pennsylvania
      • Hershey, Pennsylvania, Estados Unidos, 17033
        • Pfizer Investigational Site
    • Tennessee
      • Franklin, Tennessee, Estados Unidos, 37067
        • Pfizer Investigational Site
      • Gallatin, Tennessee, Estados Unidos, 37066
        • Pfizer Investigational Site
      • Hermitage, Tennessee, Estados Unidos, 37076
        • Pfizer Investigational Site
      • Lebanon, Tennessee, Estados Unidos, 37087
        • Pfizer Investigational Site
      • Murfreesboro, Tennessee, Estados Unidos, 37130
        • Pfizer Investigational Site
      • Nashville, Tennessee, Estados Unidos, 37203
        • Pfizer Investigational Site
      • Nashville, Tennessee, Estados Unidos, 37205
        • Pfizer Investigational Site
      • Nashville, Tennessee, Estados Unidos, 37207
        • Pfizer Investigational Site
      • Nashville, Tennessee, Estados Unidos, 37211
        • Pfizer Investigational Site
      • Nashville, Tennessee, Estados Unidos, 37203-1632
        • Pfizer Investigational Site
      • Smyrna, Tennessee, Estados Unidos, 37167
        • Pfizer Investigational Site
    • Texas
      • Burleson, Texas, Estados Unidos, 76028
        • Pfizer Investigational Site
      • Cleburne, Texas, Estados Unidos, 76031
        • Pfizer Investigational Site
      • Fort Worth, Texas, Estados Unidos, 76104
        • Pfizer Investigational Site
      • Mineral Wells, Texas, Estados Unidos, 76067
        • Pfizer Investigational Site
      • Weatherford, Texas, Estados Unidos, 76086
        • Pfizer Investigational Site
  • Francia
      • Caen Cedex 05, Francia, 14076
        • Pfizer Investigational Site
      • Villejuif, Francia, 94805
        • Pfizer Investigational Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 1
Droga: carboplatin
AUC of 6 mg*min/mL via IV infusion every 21 days for 4 cycles as per institutional practices.
Otros nombres:
  • Paraplatino
Droga: paclitaxel
175-225 mg/m2 via IV infusion every 21 days for 4 cycles as per institutional practices.
Otros nombres:
  • Taxol
Droga: sunitinib
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).
Otros nombres:
  • SUTENT, SU011248

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Proportion of Subjects Surviving at One Year
Periodo de tiempo: From start of treatment until 1 year or death
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.
From start of treatment until 1 year or death

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Progression-free Survival (PFS)
Periodo de tiempo: 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
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.
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
Time to Tumor Progression (TTP)
Periodo de tiempo: 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)
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.
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)
Duration of Response (DR)
Periodo de tiempo: 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
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.
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
Number of Subjects With Overall Confirmed Objective Disease Response
Periodo de tiempo: 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)
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.
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)
Overall Survival (OS)
Periodo de tiempo: From start of study treatment until death
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.
From start of study treatment until death
Trough Plasma Concentration (Ctrough) of Sunitinib
Periodo de tiempo: predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
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.
predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
Ctrough of SU-012662 (Sunitinib's Metabolite)
Periodo de tiempo: predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
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.
predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
Ctrough of Total Drug (Sunitinib + SU-012662)
Periodo de tiempo: predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
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.
predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
Dose-Corrected Ctrough of Sunitinib
Periodo de tiempo: predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
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.
predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
Dose-Corrected Ctrough of SU-012662 (Sunitinib's Metabolite)
Periodo de tiempo: predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
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.
predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
Dose-Corrected Ctrough of Total Drug (Sunitinib + SU-012662)
Periodo de tiempo: predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
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.
predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2
Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Concentration at Baseline
Periodo de tiempo: Baseline (Cycle 1, Day 1) of Part 2
Concentration of VEGFR3 at baseline.
Baseline (Cycle 1, Day 1) of Part 2
VEGFR3 Ratio to Baseline at Each Time Point
Periodo de tiempo: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
VEGFR3 concentration at each time point divided by VEGFR3 concentration at baseline (ratio to baseline).
Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
VEGF-C Concentration at Baseline
Periodo de tiempo: Baseline (Cycle 1, Day 1) of Part 2
Concentration of VEGF-C at baseline.
Baseline (Cycle 1, Day 1) of Part 2
VEGF-C Ratio to Baseline at Each Time Point
Periodo de tiempo: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
VEGF-C concentration at each time point divided by VEGF-C concentration at baseline (ratio to baseline).
Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
Soluble E-Selectin at Baseline
Periodo de tiempo: Baseline (Cycle 1, Day 1) of Part 2
Concentration of soluble E-Selectin at baseline.
Baseline (Cycle 1, Day 1) of Part 2
Soluble E-Selectin Ratio to Baseline at Each Time Point
Periodo de tiempo: 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
Soluble E-Selectin concentration at each time point divided by soluble E-Selectin concentration at baseline (ratio to baseline).
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
VEGFR3 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)
Periodo de tiempo: Baseline (Cycle 1, Day 1) of Part 2
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).
Baseline (Cycle 1, Day 1) of Part 2
VEGFR3 Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)
Periodo de tiempo: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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).
Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
VEGF-C at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)
Periodo de tiempo: Baseline (Cycle 1, Day 1) of Part 2
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).
Baseline (Cycle 1, Day 1) of Part 2
VEGF-C Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)
Periodo de tiempo: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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).
Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
Soluble E-Selectin at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)
Periodo de tiempo: Baseline (Cycle 1, Day 1) of Part 2
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).
Baseline (Cycle 1, Day 1) of Part 2
Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD)
Periodo de tiempo: 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
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).
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
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline
Periodo de tiempo: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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.
Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline
Periodo de tiempo: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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.
Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline
Periodo de tiempo: [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
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.
[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
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline
Periodo de tiempo: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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.
Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline
Periodo de tiempo: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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.
Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline Changes From Baseline
Periodo de tiempo: 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
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.
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
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline
Periodo de tiempo: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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.
Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline
Periodo de tiempo: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
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.
Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline
Periodo de tiempo: 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
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.
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
Immunohistochemical Staining of Paraffin Embedded Tumor Tissue
Periodo de tiempo: Screening
Previously collected tumor paraffin block (or 12-20 10-micron slides prepared for the paraffin block) for correlative laboratory analysis.
Screening
Correlation of Polymorphisms in c-Kit, Flt-3 and c-Fms to Safety of Sunitinib
Periodo de tiempo: Within 7 days of Day 1
A blood sample (6 mL) was collected and used to isolate DNA. These samples were not anonymized.
Within 7 days of Day 1
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)
Periodo de tiempo: Baseline (Part 1) to Cycle1 (Days 1 [baseline], 28), Cycles 2 and 3 (Days 1, 28), and Cycle 4 (Day 1) in Part 2
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.
Baseline (Part 1) to Cycle1 (Days 1 [baseline], 28), Cycles 2 and 3 (Days 1, 28), and Cycle 4 (Day 1) in Part 2
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13)
Periodo de tiempo: Baseline (Part 1) to Cycle1 (Days 1 [baseline], 28), Cycles 2 and 3 (Days 1, 28), and Cycle 4 (Day 1) in Part 2
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.
Baseline (Part 1) to Cycle1 (Days 1 [baseline], 28), Cycles 2 and 3 (Days 1, 28), and Cycle 4 (Day 1) in Part 2

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Pfizer

Publicaciones y enlaces útiles

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Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de septiembre de 2005

Finalización primaria (Actual)

1 de marzo de 2009

Finalización del estudio (Actual)

1 de marzo de 2009

Fechas de registro del estudio

Enviado por primera vez

8 de junio de 2005

Primero enviado que cumplió con los criterios de control de calidad

8 de junio de 2005

Publicado por primera vez (Estimar)

9 de junio de 2005

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

18 de mayo de 2010

Última actualización enviada que cumplió con los criterios de control de calidad

14 de mayo de 2010

Última verificación

1 de mayo de 2010

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • A6181057

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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