Back to resultsA Study Of Cisplatin (Or Carboplatin) And Etoposide With Or Without Figitumumab (CP-751,871) In Patients With Extensive-Stage Small Cell Lung Cancer
Primary Purpose
Small Cell Lung Carcinoma
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
figitumumab
Cisplatin (Or Carboplatin)
Etoposide
Cisplatin (Or Carboplatin)
Etoposide
Sponsored by
About this trial
This is an interventional treatment trial for Small Cell Lung Carcinoma focused on measuring Small Cell Lung Cancer, Extensive stage disease, SCLC, IGF-1R inhibitor
Eligibility Criteria
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%
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm A
Arm B
Arm Description
Figitumumab (CP-751,871) Plus Chemotherapy [Cisplatin (Or Carboplatin) And Etoposide] All drugs to be administered on a 21 day cycle
Chemotherapy [Cisplatin (Or Carboplatin) And Etoposide] All drugs to be administered on a 21 day cycle
Outcomes
Primary Outcome Measures
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].
Secondary Outcome Measures
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.
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].
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.
Maximum Observed Plasma Concentration (Cmax) of Figitumumab
Minimum Observed Plasma Trough Concentration (Cmin) of Figitumumab
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)
Maximum Observed Plasma Concentration (Cmax) of Etoposide
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
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").
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.
Pre-treatment Levels of Tumor Biomarkers Involved in Insulin-Like Growth Factor 1 (IGF-I) Signaling Pathway
Levels of Serum Circulating Insulin-like Growth Factor (IGF) Pathway Related Markers
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00977561
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description.
Study Start Date
April 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Carcinoma
Keywords
Small Cell Lung Cancer, Extensive stage disease, SCLC, IGF-1R inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
Figitumumab (CP-751,871) Plus Chemotherapy [Cisplatin (Or Carboplatin) And Etoposide] All drugs to be administered on a 21 day cycle
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
Chemotherapy [Cisplatin (Or Carboplatin) And Etoposide] All drugs to be administered on a 21 day cycle
Intervention Type
Drug
Intervention Name(s)
figitumumab
Intervention Description
Figitumumab (20 mg/kg)
Intervention Type
Drug
Intervention Name(s)
Cisplatin (Or Carboplatin)
Intervention Description
Cisplatin (75 mg/m2 IV on Day 1) or Carboplatin AUC 5
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
Etoposide (100 mg/m2 IV on Days 1, 2 and 3)
Intervention Type
Drug
Intervention Name(s)
Cisplatin (Or Carboplatin)
Intervention Description
Cisplatin (75 mg/m2 IV on Day 1) or Carboplatin AUC 5
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
Etoposide (100 mg/m2 IV on Days 1, 2 and 3)
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
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].
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
Secondary Outcome Measure Information:
Title
Number of Participants With Objective Response
Description
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.
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
Title
Overall Survival (OS)
Description
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].
Time Frame
Every 3 months until death or 12 months from the date the last participant was randomized
Title
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
Baseline up to follow-up (90 days post dose)
Title
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
Title
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
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Etoposide
Description
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
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
Title
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
Title
Percentage of Participants Reporting Positive Anti-Drug Antibodies (ADA) Response for Figitumumab
Description
Percentage of participants with positive total or neutralizing anti-drug antibody (ADA) 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
Title
Cancer Dyspnea Scale (CDS) Score
Description
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").
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
Title
Numeric Rating Scale (NRS) Score
Description
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.
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
Title
Pre-treatment Levels of Tumor Biomarkers Involved in Insulin-Like Growth Factor 1 (IGF-I) Signaling Pathway
Time Frame
Baseline prior to dosing
Title
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)
Title
Number of Total Circulating Tumor-Related Cells (CTCs) and Insulin-Like Growth Factor 1 Receptor (IGF-IR)-Expressing CTCs
Description
Pre-treatment and post-treatment counts of total and IGF-IR-positive 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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007-2197
Country
United States
Facility Name
Pfizer Investigational Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Pfizer Investigational Site
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Pfizer Investigational Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Pfizer Investigational Site
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Pfizer Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110-1094
Country
United States
Facility Name
Pfizer Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Pfizer Investigational Site
City
St. Peters
State/Province
Missouri
ZIP/Postal Code
63376
Country
United States
Facility Name
Pfizer Investigational Site
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Pfizer Investigational Site
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
Pfizer Investigational Site
City
Kernersville
State/Province
North Carolina
ZIP/Postal Code
27284
Country
United States
Facility Name
Pfizer Investigational Site
City
Lenoir
State/Province
North Carolina
ZIP/Postal Code
28645
Country
United States
Facility Name
Pfizer Investigational Site
City
Lexington
State/Province
North Carolina
ZIP/Postal Code
27295
Country
United States
Facility Name
Pfizer Investigational Site
City
Mount Airy
State/Province
North Carolina
ZIP/Postal Code
27030
Country
United States
Facility Name
Pfizer Investigational Site
City
North Wilkesboro
State/Province
North Carolina
ZIP/Postal Code
28659
Country
United States
Facility Name
Pfizer Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Pfizer Investigational Site
City
Beaverton
State/Province
Oregon
ZIP/Postal Code
97006
Country
United States
Facility Name
Pfizer Investigational Site
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Pfizer Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Pfizer Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Pfizer Investigational Site
City
Tualatin
State/Province
Oregon
ZIP/Postal Code
97062
Country
United States
Facility Name
Pfizer Investigational Site
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Pfizer Investigational Site
City
Christiansburg
State/Province
Virginia
ZIP/Postal Code
24074
Country
United States
Facility Name
Pfizer Investigational Site
City
Low Moor
State/Province
Virginia
ZIP/Postal Code
24457
Country
United States
Facility Name
Pfizer Investigational Site
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Pfizer Investigational Site
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Facility Name
Pfizer Investigational Site
City
Wytheville
State/Province
Virginia
ZIP/Postal Code
24382
Country
United States
Facility Name
Pfizer Investigational Site
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Pfizer Investigational Site
City
Federal Way
State/Province
Washington
ZIP/Postal Code
98003
Country
United States
Facility Name
Pfizer Investigational Site
City
Gig Harbor
State/Province
Washington
ZIP/Postal Code
98332
Country
United States
Facility Name
Pfizer Investigational Site
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
Pfizer Investigational Site
City
Lakewood
State/Province
Washington
ZIP/Postal Code
98499
Country
United States
Facility Name
Pfizer Investigational Site
City
Puyallup
State/Province
Washington
ZIP/Postal Code
98372
Country
United States
Facility Name
Pfizer Investigational Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Pfizer Investigational Site
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Levis
State/Province
Quebec
ZIP/Postal Code
G6V 3Z1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Deszk
ZIP/Postal Code
6772
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Farkasgyepu
ZIP/Postal Code
8582
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Torokbalint
ZIP/Postal Code
2045
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Pfizer Investigational Site
City
Las Palmas de Gran Canaria
ZIP/Postal Code
35016
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Pfizer Investigational Site
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Pfizer Investigational Site
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Pfizer Investigational Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Pfizer Investigational Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4021032&StudyName=A%20Study%20Of%20Cisplatin%20%28Or%20Carboplatin%29%20And%20Etoposide%20With%20Or%20Without%20Figitumumab%20%28CP-751%2C871%29%20In%20Patients%20With%20Extensive-Stage%20Smal
Description
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Learn more about this trial
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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