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

• 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 ] [ Designated as safety issue: No ]
  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].
  
  

• 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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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) ] [ Designated as safety issue: Yes ]
  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 ] [ Designated as safety issue: No ]
  
• 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 ] [ Designated as safety issue: No ]
  
• 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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  
• 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 ] [ Designated as safety issue: Yes ]
  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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  
• 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) ] [ Designated as safety issue: No ]
  
• 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) ] [ Designated as safety issue: No ]
  Pre-treatment and post-treatment counts of total and IGF-IR-positive CTCs
  
  

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.