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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

NCT ID: NCT00977561

Last Updated: 2013-02-25

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Small Cell Lung Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

Figitumumab (CP-751,871) Plus Chemotherapy \[Cisplatin (Or Carboplatin) And Etoposide\] All drugs to be administered on a 21 day cycle

Group Type EXPERIMENTAL

figitumumab

Intervention Type DRUG

Figitumumab (20 mg/kg)

Cisplatin (Or Carboplatin)

Intervention Type DRUG

Cisplatin (75 mg/m2 IV on Day 1) or Carboplatin AUC 5

Etoposide

Intervention Type DRUG

Etoposide (100 mg/m2 IV on Days 1, 2 and 3)

Arm B

Chemotherapy \[Cisplatin (Or Carboplatin) And Etoposide\] All drugs to be administered on a 21 day cycle

Group Type ACTIVE_COMPARATOR

Cisplatin (Or Carboplatin)

Intervention Type DRUG

Cisplatin (75 mg/m2 IV on Day 1) or Carboplatin AUC 5

Etoposide

Intervention Type DRUG

Etoposide (100 mg/m2 IV on Days 1, 2 and 3)

Interventions

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figitumumab

Figitumumab (20 mg/kg)

Intervention Type DRUG

Cisplatin (Or Carboplatin)

Cisplatin (75 mg/m2 IV on Day 1) or Carboplatin AUC 5

Intervention Type DRUG

Etoposide

Etoposide (100 mg/m2 IV on Days 1, 2 and 3)

Intervention Type DRUG

Cisplatin (Or Carboplatin)

Cisplatin (75 mg/m2 IV on Day 1) or Carboplatin AUC 5

Intervention Type DRUG

Etoposide

Etoposide (100 mg/m2 IV on Days 1, 2 and 3)

Intervention Type DRUG

Eligibility Criteria

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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%
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Washington D.C., District of Columbia, United States

Site Status

Pfizer Investigational Site

Washington D.C., District of Columbia, United States

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Pfizer Investigational Site

Marrero, Louisiana, United States

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Pfizer Investigational Site

Metairie, Louisiana, United States

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Pfizer Investigational Site

City of Saint Peters, Missouri, United States

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Creve Coeur, Missouri, United States

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Pfizer Investigational Site

St Louis, Missouri, United States

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St Louis, Missouri, United States

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Morristown, New Jersey, United States

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Hickory, North Carolina, United States

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Kernersville, North Carolina, United States

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Pfizer Investigational Site

Lenoir, North Carolina, United States

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Lexington, North Carolina, United States

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Mount Airy, North Carolina, United States

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Pfizer Investigational Site

North Wilkesboro, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Beaverton, Oregon, United States

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Gresham, Oregon, United States

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Portland, Oregon, United States

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Portland, Oregon, United States

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Tualatin, Oregon, United States

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West Reading, Pennsylvania, United States

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Christiansburg, Virginia, United States

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Low Moor, Virginia, United States

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Roanoke, Virginia, United States

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Salem, Virginia, United States

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Wytheville, Virginia, United States

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Everett, Washington, United States

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Federal Way, Washington, United States

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Gig Harbor, Washington, United States

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Kennewick, Washington, United States

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Lakewood, Washington, United States

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Puyallup, Washington, United States

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Pfizer Investigational Site

Tacoma, Washington, United States

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Pfizer Investigational Site

Greater Sudbury, Ontario, Canada

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Oshawa, Ontario, Canada

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Lévis, Quebec, Canada

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Montreal, Quebec, Canada

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Pfizer Investigational Site

Budapest, , Hungary

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Debrecen, , Hungary

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Pfizer Investigational Site

Deszk, , Hungary

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Pfizer Investigational Site

Farkasgyepű, , Hungary

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Pfizer Investigational Site

Törökbálint, , Hungary

Site Status

Pfizer Investigational Site

Barcelona, Barcelona, Spain

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Pfizer Investigational Site

Barcelona, Barcelona, Spain

Site Status

Pfizer Investigational Site

Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain

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Pfizer Investigational Site

Madrid, Madrid, Spain

Site Status

Pfizer Investigational Site

Málaga, Malaga, Spain

Site Status

Pfizer Investigational Site

Seville, Sevilla, Spain

Site Status

Pfizer Investigational Site

Seville, Sevilla, Spain

Site Status

Pfizer Investigational Site

Valencia, Valencia, Spain

Site Status

Countries

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United States Canada Hungary Spain

Related Links

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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

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

Other Identifiers

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A4021032

Identifier Type: -

Identifier Source: org_study_id

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