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Trial record 1 of 1 for:    NCT00977561
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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

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ClinicalTrials.gov Identifier: NCT00977561
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : September 15, 2009
Results First Posted : February 25, 2013
Last Update Posted : February 25, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 10, 2009
First Posted Date  ICMJE September 15, 2009
Results First Submitted Date  ICMJE January 18, 2013
Results First Posted Date  ICMJE February 25, 2013
Last Update Posted Date February 25, 2013
Study Start Date  ICMJE April 2010
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2013)
Progression-Free Survival (PFS) [ Time Frame: 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].
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2009)
Progression Free Survival (PFS) defined as the time from randomization to disease progression or death due to any cause, whichever occurs first. [ Time Frame: disease progression or death ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2013)
  • Number of Participants With Objective Response [ Time Frame: 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.
  • Overall Survival (OS) [ Time Frame: 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].
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 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.
  • Maximum Observed Plasma Concentration (Cmax) of Figitumumab [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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)
  • Maximum Observed Plasma Concentration (Cmax) of Etoposide [ Time Frame: 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 [ Time Frame: 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
  • Cancer Dyspnea Scale (CDS) Score [ Time Frame: 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").
  • Numeric Rating Scale (NRS) Score [ Time Frame: 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.
  • Pre-treatment Levels of Tumor Biomarkers Involved in Insulin-Like Growth Factor 1 (IGF-I) Signaling Pathway [ Time Frame: Baseline prior to dosing ]
  • Levels of Serum Circulating Insulin-like Growth Factor (IGF) Pathway Related Markers [ Time Frame: 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 [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2009)
  • Objective Response defined per RECIST (Response Evaluation Criterion in Solid Tumors) [ Time Frame: 2 years ]
  • Overall Survival defined as the time period from randomization to death due to any cause [ Time Frame: 2 years ]
  • Overall Safety and Toxicity Profile characterized by type, frequency and severity, as graded using the NCI/CTEP Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: 2 years ]
  • Pharmacokinetics of figitumumab as measured by peak (Cmax) and trough (Ctrough) concentrations. PK parameters of etoposide in the absence and presence of figitumumab in an initial group of 12 patients in Arm A enrolled at designated etoposide PK sites [ Time Frame: 90 days post last dose ]
  • Patient Reported Outcome (PRO) of disease-related symptoms as measured by the Cancer Dyspnea Scale (CDS) and Numeric Rating Scale (NRS) for "worst" pain [ Time Frame: 1 year ]
  • Levels of tumor biomarkers indicative of deregulated growth signalling in Small Cell Lung Cancer (SCLC) [ Time Frame: 1 year ]
  • Levels of blood biomarkers associated with SCLC pathology. Quantities of total and IGF-IR-expressing circulating tumor cells (CTC) before and after treatment [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Of Cisplatin (Or Carboplatin) And Etoposide With Or Without Figitumumab (CP-751,871) In Patients With Extensive-Stage Small Cell Lung Cancer
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Small Cell Lung Carcinoma
Intervention  ICMJE
  • Drug: figitumumab
    Figitumumab (20 mg/kg)
  • Drug: Cisplatin (Or Carboplatin)
    Cisplatin (75 mg/m2 IV on Day 1) or Carboplatin AUC 5
  • Drug: Etoposide
    Etoposide (100 mg/m2 IV on Days 1, 2 and 3)
Study Arms  ICMJE
  • Experimental: Arm A
    Figitumumab (CP-751,871) Plus Chemotherapy [Cisplatin (Or Carboplatin) And Etoposide] All drugs to be administered on a 21 day cycle
    Interventions:
    • Drug: figitumumab
    • Drug: Cisplatin (Or Carboplatin)
    • Drug: Etoposide
  • Active Comparator: Arm B
    Chemotherapy [Cisplatin (Or Carboplatin) And Etoposide] All drugs to be administered on a 21 day cycle
    Interventions:
    • Drug: Cisplatin (Or Carboplatin)
    • Drug: Etoposide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 18, 2011)
9
Original Estimated Enrollment  ICMJE
 (submitted: September 14, 2009)
120
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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%
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Hungary,   Spain,   United States
Removed Location Countries Bulgaria
 
Administrative Information
NCT Number  ICMJE NCT00977561
Other Study ID Numbers  ICMJE A4021032
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP