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A Study Of Cisplatin (Or Carboplatin) And Etoposide With Or Without Figitumumab (CP-751,871) In Patients With Extensive-Stage Small Cell Lung Cancer

18 januari 2013 uppdaterad av: Pfizer

A Phase 2, Randomized, Open Label Study Of Figitumumab (CP-751,871) Plus Cisplatin (Or Carboplatin) And Etoposide, Versus Cisplatin (Or Carboplatin) And Etoposide Alone, As First Line Treatment In Patients With Extensive Stage Disease Small Cell Lung Cancer

This study will summarize the safety of patients receiving figitumumab combined with etoposide and cisplatin (or carboplatin) vs. patients receiving etoposide and cisplatin (or carboplatin) alone as first line treatment for extensive stage disease Small Cell Lung Cancer.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

The study prematurely discontinued on January 26, 2011 due to slow enrollment. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.

Studietyp

Interventionell

Inskrivning (Faktisk)

9

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • District of Columbia
      • Washington, District of Columbia, Förenta staterna, 20007-2197
        • Pfizer Investigational Site
      • Washington, District of Columbia, Förenta staterna, 20007
        • Pfizer Investigational Site
    • Louisiana
      • Marrero, Louisiana, Förenta staterna, 70072
        • Pfizer Investigational Site
      • Metairie, Louisiana, Förenta staterna, 70006
        • Pfizer Investigational Site
    • Missouri
      • Creve Coeur, Missouri, Förenta staterna, 63141
        • Pfizer Investigational Site
      • St. Louis, Missouri, Förenta staterna, 63110
        • Pfizer Investigational Site
      • St. Louis, Missouri, Förenta staterna, 63110-1094
        • Pfizer Investigational Site
      • St. Peters, Missouri, Förenta staterna, 63376
        • Pfizer Investigational Site
    • New Jersey
      • Morristown, New Jersey, Förenta staterna, 07962
        • Pfizer Investigational Site
    • North Carolina
      • Hickory, North Carolina, Förenta staterna, 28602
        • Pfizer Investigational Site
      • Kernersville, North Carolina, Förenta staterna, 27284
        • Pfizer Investigational Site
      • Lenoir, North Carolina, Förenta staterna, 28645
        • Pfizer Investigational Site
      • Lexington, North Carolina, Förenta staterna, 27295
        • Pfizer Investigational Site
      • Mount Airy, North Carolina, Förenta staterna, 27030
        • Pfizer Investigational Site
      • North Wilkesboro, North Carolina, Förenta staterna, 28659
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, Förenta staterna, 27103
        • Pfizer Investigational Site
    • Oregon
      • Beaverton, Oregon, Förenta staterna, 97006
        • Pfizer Investigational Site
      • Gresham, Oregon, Förenta staterna, 97030
        • Pfizer Investigational Site
      • Portland, Oregon, Förenta staterna, 97210
        • Pfizer Investigational Site
      • Portland, Oregon, Förenta staterna, 97239
        • Pfizer Investigational Site
      • Tualatin, Oregon, Förenta staterna, 97062
        • Pfizer Investigational Site
    • Pennsylvania
      • West Reading, Pennsylvania, Förenta staterna, 19611
        • Pfizer Investigational Site
    • Virginia
      • Christiansburg, Virginia, Förenta staterna, 24074
        • Pfizer Investigational Site
      • Low Moor, Virginia, Förenta staterna, 24457
        • Pfizer Investigational Site
      • Roanoke, Virginia, Förenta staterna, 24014
        • Pfizer Investigational Site
      • Salem, Virginia, Förenta staterna, 24153
        • Pfizer Investigational Site
      • Wytheville, Virginia, Förenta staterna, 24382
        • Pfizer Investigational Site
    • Washington
      • Everett, Washington, Förenta staterna, 98201
        • Pfizer Investigational Site
      • Federal Way, Washington, Förenta staterna, 98003
        • Pfizer Investigational Site
      • Gig Harbor, Washington, Förenta staterna, 98332
        • Pfizer Investigational Site
      • Kennewick, Washington, Förenta staterna, 99336
        • Pfizer Investigational Site
      • Lakewood, Washington, Förenta staterna, 98499
        • Pfizer Investigational Site
      • Puyallup, Washington, Förenta staterna, 98372
        • Pfizer Investigational Site
      • Tacoma, Washington, Förenta staterna, 98405
        • Pfizer Investigational Site
  • Kanada
    • Ontario
      • Oshawa, Ontario, Kanada, L1G 2B9
        • Pfizer Investigational Site
      • Sudbury, Ontario, Kanada, P3E 5J1
        • Pfizer Investigational Site
    • Quebec
      • Levis, Quebec, Kanada, G6V 3Z1
        • Pfizer Investigational Site
      • Montreal, Quebec, Kanada, H4J 1C5
        • Pfizer Investigational Site
  • Spanien
      • Barcelona, Spanien, 08036
        • Pfizer Investigational Site
      • Barcelona, Spanien, 08025
        • Pfizer Investigational Site
      • Las Palmas de Gran Canaria, Spanien, 35016
        • Pfizer Investigational Site
      • Madrid, Spanien, 28041
        • Pfizer Investigational Site
      • Malaga, Spanien, 29010
        • Pfizer Investigational Site
      • Sevilla, Spanien, 41013
        • Pfizer Investigational Site
      • Sevilla, Spanien, 41009
        • Pfizer Investigational Site
      • Valencia, Spanien, 46026
        • Pfizer Investigational Site
  • Ungern
      • Budapest, Ungern, 1125
        • Pfizer Investigational Site
      • Debrecen, Ungern, 4032
        • Pfizer Investigational Site
      • Deszk, Ungern, 6772
        • Pfizer Investigational Site
      • Farkasgyepu, Ungern, 8582
        • Pfizer Investigational Site
      • Torokbalint, Ungern, 2045
        • Pfizer Investigational Site

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Histologically confirmed diagnosis of extensive stage disease Small Cell Lung Cancer (SCLC), with tumor biopsy sample required.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. Total IGF-1 > or = 120 ng/ml

Exclusion Criteria:

  • Any prior systemic therapy for Small Cell Lung Cancer (SCLC)
  • HbA1c > or = 5.7%

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Arm A
Figitumumab (CP-751,871) Plus Chemotherapy [Cisplatin (Or Carboplatin) And Etoposide] All drugs to be administered on a 21 day cycle
Läkemedel: figitumumab
Figitumumab (20 mg/kg)
Läkemedel: Cisplatin (Or Carboplatin)
Cisplatin (75 mg/m2 IV on Day 1) or Carboplatin AUC 5
Läkemedel: Etoposide
Etoposide (100 mg/m2 IV on Days 1, 2 and 3)
Aktiv komparator: Arm B
Chemotherapy [Cisplatin (Or Carboplatin) And Etoposide] All drugs to be administered on a 21 day cycle
Läkemedel: Cisplatin (Or Carboplatin)
Cisplatin (75 mg/m2 IV on Day 1) or Carboplatin AUC 5
Läkemedel: Etoposide
Etoposide (100 mg/m2 IV on Days 1, 2 and 3)

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Progression-Free Survival (PFS)
Tidsram: Baseline, every 2nd cycle (between Day 15-21, 1 cycle = 21 days) starting with Cycle 2 until disease progression, at the end of treatment visit (if more than 28 days have passed since last evaluation); and every 6 weeks until disease progression
Median time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS time (days) = [event (progression or death) date or censor date - date of randomization + 1].
Baseline, every 2nd cycle (between Day 15-21, 1 cycle = 21 days) starting with Cycle 2 until disease progression, at the end of treatment visit (if more than 28 days have passed since last evaluation); and every 6 weeks until disease progression

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Participants With Objective Response
Tidsram: Baseline, every 2nd cycle (between Day 15-21, 1 cycle = 21 days) starting with Cycle 2 until disease progression, at the end of treatment visit (if more than 28 days have passed since last evaluation); and every 6 weeks until disease progression
Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST.
Baseline, every 2nd cycle (between Day 15-21, 1 cycle = 21 days) starting with Cycle 2 until disease progression, at the end of treatment visit (if more than 28 days have passed since last evaluation); and every 6 weeks until disease progression
Overall Survival (OS)
Tidsram: Every 3 months until death or 12 months from the date the last participant was randomized
Overall survival was the duration from enrollment to death due to any cause. For participants who are alive, overall survival was censored at the last contact. Survival time (days) = [death date (last known alive date) - date of randomization +1].
Every 3 months until death or 12 months from the date the last participant was randomized
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsram: Baseline up to follow-up (90 days post dose)
AEs are any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study treatment. The event does not need to be causally related to the study treatment. SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly or birth defect in the offspring of a study subject.
Baseline up to follow-up (90 days post dose)
Maximum Observed Plasma Concentration (Cmax) of Figitumumab
Tidsram: Cycle 1, Day 2; Day 1 of Cycles 2, 4, 5, 6, 10 and 15; Day 28 and Day 90 post last figitumumab dose
Cycle 1, Day 2; Day 1 of Cycles 2, 4, 5, 6, 10 and 15; Day 28 and Day 90 post last figitumumab dose
Minimum Observed Plasma Trough Concentration (Cmin) of Figitumumab
Tidsram: Cycle 1, Day 2; Day 1 of Cycles 2, 4, 5, 6, 10 and 15; Day 28 and Day 90 post last figitumumab dose
Cycle 1, Day 2; Day 1 of Cycles 2, 4, 5, 6, 10 and 15; Day 28 and Day 90 post last figitumumab dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Etoposide
Tidsram: Cycles 1 and 2, Day 1 and Day 2 (within 3 hours prior to Day 1 etoposide infusion; 1, 1.5, 2, 3, 6, and 24 hours post Day 1 etoposide infusion); Cycles 4 and 5, Day 2: 24 hours post Day 1 etoposide infusion
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Cycles 1 and 2, Day 1 and Day 2 (within 3 hours prior to Day 1 etoposide infusion; 1, 1.5, 2, 3, 6, and 24 hours post Day 1 etoposide infusion); Cycles 4 and 5, Day 2: 24 hours post Day 1 etoposide infusion
Maximum Observed Plasma Concentration (Cmax) of Etoposide
Tidsram: Cycles 1 and 2, Day 1 and Day 2 (within 3 hours prior to Day 1 etoposide infusion; 1, 1.5, 2, 3, 6, and 24 hours post Day 1 etoposide infusion); Cycles 4 and 5, Day 2: 24 hours post Day 1 etoposide infusion
Cycles 1 and 2, Day 1 and Day 2 (within 3 hours prior to Day 1 etoposide infusion; 1, 1.5, 2, 3, 6, and 24 hours post Day 1 etoposide infusion); Cycles 4 and 5, Day 2: 24 hours post Day 1 etoposide infusion
Percentage of Participants Reporting Positive Anti-Drug Antibodies (ADA) Response for Figitumumab
Tidsram: Day 2 of Cycle 1 (or Day 1 of the initial cycle starting single agent figitumumab); Day 1 of Cycles 2 and 4; Day 28 and Day 90 post last figitumumab dose
Percentage of participants with positive total or neutralizing anti-drug antibody (ADA) for figitumumab
Day 2 of Cycle 1 (or Day 1 of the initial cycle starting single agent figitumumab); Day 1 of Cycles 2 and 4; Day 28 and Day 90 post last figitumumab dose
Cancer Dyspnea Scale (CDS) Score
Tidsram: Day 1 of every cycle (up to 17 cycles), at the end of treatment visit (28 days post last dose); then every 6 weeks until disease progression
The Cancer Dyspnea Scale consists of 12 questions that assess 3 domains of dyspnea (sense of effort, anxiety and discomfort) related to lung cancer. The questions are answered on 5-point Likert scale ranging from 1 to 5 (1 "Not at All" to 5 "Very Much").
Day 1 of every cycle (up to 17 cycles), at the end of treatment visit (28 days post last dose); then every 6 weeks until disease progression
Numeric Rating Scale (NRS) Score
Tidsram: Day 1 of every cycle (up to 17 cycles), at the end of treatment visit (28 days post last dose); then every 6 weeks until disease progression
The Numeric Rating Scale (NRS) is a 1-item self-reported questionnaire designed to assess "worst pain" severity. Overall scores range from 0 to 10, with low scores representing a lower level of pain.
Day 1 of every cycle (up to 17 cycles), at the end of treatment visit (28 days post last dose); then every 6 weeks until disease progression
Pre-treatment Levels of Tumor Biomarkers Involved in Insulin-Like Growth Factor 1 (IGF-I) Signaling Pathway
Tidsram: Baseline prior to dosing
Baseline prior to dosing
Levels of Serum Circulating Insulin-like Growth Factor (IGF) Pathway Related Markers
Tidsram: Baseline (Cycle 1, Day 1 prior to dosing), Cycle 4 (Day 1), at the end of treatment visit (28 days post last figitumumab dose)
Baseline (Cycle 1, Day 1 prior to dosing), Cycle 4 (Day 1), at the end of treatment visit (28 days post last figitumumab dose)
Number of Total Circulating Tumor-Related Cells (CTCs) and Insulin-Like Growth Factor 1 Receptor (IGF-IR)-Expressing CTCs
Tidsram: Baseline (Cycle 1, Day 1), Cycle 4 (Day 1) and at the end of treatment visit (28 days post last figitumumab dose)
Pre-treatment and post-treatment counts of total and IGF-IR-positive CTCs
Baseline (Cycle 1, Day 1), Cycle 4 (Day 1) and at the end of treatment visit (28 days post last figitumumab dose)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Pfizer

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2010

Primärt slutförande (Faktisk)

1 oktober 2011

Avslutad studie (Faktisk)

1 oktober 2011

Studieregistreringsdatum

Först inskickad

10 september 2009

Först inskickad som uppfyllde QC-kriterierna

14 september 2009

Första postat (Uppskatta)

15 september 2009

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

25 februari 2013

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

18 januari 2013

Senast verifierad

1 januari 2013

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • A4021032

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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