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

Small Cell Lung Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00977561
• Other study ID #: A4021032
• Status: Terminated
• Phase: Phase 2
• First received: September 10, 2009
• Last updated: January 18, 2013
• Start date: April 2010
• Est. completion date: October 2011

Study information

• Verified date: January 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• figitumumab
Figitumumab (20 mg/kg)
• Cisplatin (Or Carboplatin)
Cisplatin (75 mg/m2 IV on Day 1) or Carboplatin AUC 5
• Etoposide
Etoposide (100 mg/m2 IV on Days 1, 2 and 3)
• Cisplatin (Or Carboplatin)
Cisplatin (75 mg/m2 IV on Day 1) or Carboplatin AUC 5
• Etoposide
Etoposide (100 mg/m2 IV on Days 1, 2 and 3)

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Levis	Quebec
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Oshawa	Ontario
Canada	Pfizer Investigational Site	Sudbury	Ontario
Hungary	Pfizer Investigational Site	Budapest
Hungary	Pfizer Investigational Site	Debrecen
Hungary	Pfizer Investigational Site	Deszk
Hungary	Pfizer Investigational Site	Farkasgyepu
Hungary	Pfizer Investigational Site	Torokbalint
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Las Palmas de Gran Canaria
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Malaga
Spain	Pfizer Investigational Site	Sevilla
Spain	Pfizer Investigational Site	Sevilla
Spain	Pfizer Investigational Site	Valencia
United States	Pfizer Investigational Site	Beaverton	Oregon
United States	Pfizer Investigational Site	Christiansburg	Virginia
United States	Pfizer Investigational Site	Creve Coeur	Missouri
United States	Pfizer Investigational Site	Everett	Washington
United States	Pfizer Investigational Site	Federal Way	Washington
United States	Pfizer Investigational Site	Gig Harbor	Washington
United States	Pfizer Investigational Site	Gresham	Oregon
United States	Pfizer Investigational Site	Hickory	North Carolina
United States	Pfizer Investigational Site	Kennewick	Washington
United States	Pfizer Investigational Site	Kernersville	North Carolina
United States	Pfizer Investigational Site	Lakewood	Washington
United States	Pfizer Investigational Site	Lenoir	North Carolina
United States	Pfizer Investigational Site	Lexington	North Carolina
United States	Pfizer Investigational Site	Low Moor	Virginia
United States	Pfizer Investigational Site	Marrero	Louisiana
United States	Pfizer Investigational Site	Metairie	Louisiana
United States	Pfizer Investigational Site	Morristown	New Jersey
United States	Pfizer Investigational Site	Mount Airy	North Carolina
United States	Pfizer Investigational Site	North Wilkesboro	North Carolina
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Puyallup	Washington
United States	Pfizer Investigational Site	Roanoke	Virginia
United States	Pfizer Investigational Site	Salem	Virginia
United States	Pfizer Investigational Site	St. Louis	Missouri
United States	Pfizer Investigational Site	St. Louis	Missouri
United States	Pfizer Investigational Site	St. Peters	Missouri
United States	Pfizer Investigational Site	Tacoma	Washington
United States	Pfizer Investigational Site	Tualatin	Oregon
United States	Pfizer Investigational Site	Washington	District of Columbia
United States	Pfizer Investigational Site	Washington	District of Columbia
United States	Pfizer Investigational Site	West Reading	Pennsylvania
United States	Pfizer Investigational Site	Winston-Salem	North Carolina
United States	Pfizer Investigational Site	Wytheville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Hungary,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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)	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	Pre-treatment Levels of Tumor Biomarkers Involved in Insulin-Like Growth Factor 1 (IGF-I) Signaling Pathway		Baseline prior to dosing	No
Secondary	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)	No
Secondary	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)	No

External Links

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