Clinical trial NCT00977561: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Small Cell Lung Carcinoma
Keywords: Small Cell Lung Cancer
Extensive stage disease
SCLC
IGF-1R inhibitor
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-09-15
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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%

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: 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 outcomes:
measure: Number of Participants With Objective Response
timeFrame: 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
measure: Overall Survival (OS)
timeFrame: Every 3 months until death or 12 months from the date the last participant was randomized
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to follow-up (90 days post dose)
measure: Maximum Observed Plasma Concentration (Cmax) of Figitumumab
timeFrame: Cycle 1, Day 2; Day 1 of Cycles 2, 4, 5, 6, 10 and 15; Day 28 and Day 90 post last figitumumab dose
measure: Minimum Observed Plasma Trough Concentration (Cmin) of Figitumumab
timeFrame: Cycle 1, Day 2; Day 1 of Cycles 2, 4, 5, 6, 10 and 15; Day 28 and Day 90 post last figitumumab dose
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Etoposide
timeFrame: 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
measure: Maximum Observed Plasma Concentration (Cmax) of Etoposide
timeFrame: 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
measure: Percentage of Participants Reporting Positive Anti-Drug Antibodies (ADA) Response for Figitumumab
timeFrame: 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
measure: Cancer Dyspnea Scale (CDS) Score
timeFrame: 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
measure: Numeric Rating Scale (NRS) Score
timeFrame: 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
measure: Pre-treatment Levels of Tumor Biomarkers Involved in Insulin-Like Growth Factor 1 (IGF-I) Signaling Pathway
timeFrame: Baseline prior to dosing
measure: Levels of Serum Circulating Insulin-like Growth Factor (IGF) Pathway Related Markers
timeFrame: Baseline (Cycle 1, Day 1 prior to dosing), Cycle 4 (Day 1), at the end of treatment visit (28 days post last figitumumab dose)
measure: Number of Total Circulating Tumor-Related Cells (CTCs) and Insulin-Like Growth Factor 1 Receptor (IGF-IR)-Expressing CTCs
timeFrame: Baseline (Cycle 1, Day 1), Cycle 4 (Day 1) and at the end of treatment visit (28 days post last figitumumab dose)
Other outcomes:
Locations:
city: Washington
country: United States
facility: Pfizer Investigational Site
state: District of Columbia
city: Washington
country: United States
facility: Pfizer Investigational Site
state: District of Columbia
city: Marrero
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Metairie
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Creve Coeur
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St. Peters
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Morristown
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Hickory
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Kernersville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Lenoir
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Mount Airy
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: North Wilkesboro
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Beaverton
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Gresham
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Tualatin
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: West Reading
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Christiansburg
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Low Moor
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Roanoke
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Salem
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Wytheville
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Everett
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Federal Way
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Gig Harbor
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Kennewick
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Lakewood
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Puyallup
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Tacoma
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Oshawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Sudbury
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Levis
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Debrecen
country: Hungary
facility: Pfizer Investigational Site
city: Deszk
country: Hungary
facility: Pfizer Investigational Site
city: Farkasgyepu
country: Hungary
facility: Pfizer Investigational Site
city: Torokbalint
country: Hungary
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Las Palmas de Gran Canaria
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Malaga
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: