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

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.

Study Overview

• Status: Terminated
• Conditions: Small Cell Lung Carcinoma
• Intervention / Treatment: Drug: figitumumab; Drug: Cisplatin (Or Carboplatin); Drug: Etoposide

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: Interventional
• Enrollment (Actual): 9
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

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 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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; Figitumumab (CP-751,871) Plus Chemotherapy [Cisplatin (Or Carboplatin) And Etoposide] All drugs to be administered on a 21 day cycle	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)
Active Comparator: Arm B; Chemotherapy [Cisplatin (Or Carboplatin) And Etoposide] All drugs to be administered on a 21 day cycle	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Objective Response	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)	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)	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		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		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	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		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	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	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	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		Baseline prior to dosing
Levels of Serum Circulating Insulin-like Growth Factor (IGF) Pathway Related Markers		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	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)

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: September 10, 2009
• First Submitted That Met QC Criteria: September 14, 2009
• First Posted (Estimate): September 15, 2009

Study Record Updates

• Last Update Posted (Estimate): February 25, 2013
• Last Update Submitted That Met QC Criteria: January 18, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Small Cell Lung Cancer; SCLC; IGF-1R inhibitor; Extensive stage disease
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Carboplatin; Etoposide; Etoposide phosphate; Cisplatin
• Other Study ID Numbers: A4021032