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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Small Cell Lung Carcinoma

Intervention: figitumumab (Drug); Cisplatin (Or Carboplatin) (Drug); Etoposide (Drug); Cisplatin (Or Carboplatin) (Drug); Etoposide (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

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

Primary outcome: Progression-Free Survival (PFS)

Secondary outcome:

Number of Participants With Objective Response

Overall Survival (OS)

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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

Maximum Observed Plasma Concentration (Cmax) of Etoposide

Percentage of Participants Reporting Positive Anti-Drug Antibodies (ADA) Response for Figitumumab

Cancer Dyspnea Scale (CDS) Score

Numeric Rating Scale (NRS) Score

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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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%

Locations and Contacts

Pfizer Investigational Site, Budapest 1125, Hungary

Pfizer Investigational Site, Debrecen 4032, Hungary

Pfizer Investigational Site, Deszk 6772, Hungary

Pfizer Investigational Site, Farkasgyepu 8582, Hungary

Pfizer Investigational Site, Torokbalint 2045, Hungary

Pfizer Investigational Site, Barcelona 08025, Spain

Pfizer Investigational Site, Barcelona 08036, Spain

Pfizer Investigational Site, Las Palmas de Gran Canaria 35016, Spain

Pfizer Investigational Site, Madrid 28041, Spain

Pfizer Investigational Site, Malaga 29010, Spain

Pfizer Investigational Site, Sevilla 41009, Spain

Pfizer Investigational Site, Sevilla 41013, Spain

Pfizer Investigational Site, Valencia 46026, Spain

Pfizer Investigational Site, Washington, District of Columbia 20007-2197, United States

Pfizer Investigational Site, Washington, District of Columbia 20007, United States

Pfizer Investigational Site, Marrero, Louisiana 70072, United States

Pfizer Investigational Site, Metairie, Louisiana 70006, United States

Pfizer Investigational Site, Creve Coeur, Missouri 63141, United States

Pfizer Investigational Site, St. Louis, Missouri 63110, United States

Pfizer Investigational Site, St. Louis, Missouri 63110-1094, United States

Pfizer Investigational Site, St. Peters, Missouri 63376, United States

Pfizer Investigational Site, Morristown, New Jersey 07962, United States

Pfizer Investigational Site, Hickory, North Carolina 28602, United States

Pfizer Investigational Site, Kernersville, North Carolina 27284, United States

Pfizer Investigational Site, Lenoir, North Carolina 28645, United States

Pfizer Investigational Site, Lexington, North Carolina 27295, United States

Pfizer Investigational Site, Mount Airy, North Carolina 27030, United States

Pfizer Investigational Site, North Wilkesboro, North Carolina 28659, United States

Pfizer Investigational Site, Winston-Salem, North Carolina 27103, United States

Pfizer Investigational Site, Oshawa, Ontario L1G 2B9, Canada

Pfizer Investigational Site, Sudbury, Ontario P3E 5J1, Canada

Pfizer Investigational Site, Beaverton, Oregon 97006, United States

Pfizer Investigational Site, Gresham, Oregon 97030, United States

Pfizer Investigational Site, Portland, Oregon 97210, United States

Pfizer Investigational Site, Portland, Oregon 97239, United States

Pfizer Investigational Site, Tualatin, Oregon 97062, United States

Pfizer Investigational Site, West Reading, Pennsylvania 19611, United States

Pfizer Investigational Site, Levis, Quebec G6V 3Z1, Canada

Pfizer Investigational Site, Montreal, Quebec H4J 1C5, Canada

Pfizer Investigational Site, Christiansburg, Virginia 24074, United States

Pfizer Investigational Site, Low Moor, Virginia 24457, United States

Pfizer Investigational Site, Roanoke, Virginia 24014, United States

Pfizer Investigational Site, Salem, Virginia 24153, United States

Pfizer Investigational Site, Wytheville, Virginia 24382, United States

Pfizer Investigational Site, Everett, Washington 98201, United States

Pfizer Investigational Site, Federal Way, Washington 98003, United States

Pfizer Investigational Site, Gig Harbor, Washington 98332, United States

Pfizer Investigational Site, Kennewick, Washington 99336, United States

Pfizer Investigational Site, Lakewood, Washington 98499, United States

Pfizer Investigational Site, Puyallup, Washington 98372, United States

Pfizer Investigational Site, Tacoma, Washington 98405, United States

Additional Information

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

Starting date: April 2010
Last updated: January 18, 2013

Page last updated: August 23, 2015

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