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

NCT00977561 | Terminated Phase 2 Results

• 1 other identifier: A4021032
• Study Type: interventional
• Target: 9
• Locations: 4 countries
• Sites: 51

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.

Conditions

Small Cell Lung Carcinoma

Keywords

Small Cell Lung Cancer; Extensive stage disease; SCLC; IGF-1R inhibitor

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (13)

• Number of Participants With Objective Response

  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

• Overall Survival (OS)

  Every 3 months until death or 12 months from the date the last participant was randomized

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

  Baseline up to follow-up (90 days post dose)

• 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

• 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

Study Arms (2)

Arm A

EXPERIMENTAL

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

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

Arm B

ACTIVE COMPARATOR

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

Drug: Cisplatin (Or Carboplatin); Drug: Etoposide

Interventions

figitumumab DRUG

Figitumumab (20 mg/kg)

Arm A

Cisplatin (Or Carboplatin) DRUG

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

Arm A

Etoposide DRUG

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

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any prior systemic therapy for Small Cell Lung Cancer (SCLC)
• HbA1c \> or = 5.7%

Sponsors & Collaborators

• Pfizer: lead

Study Sites (51)

Pfizer Investigational Site

Washington D.C., District of Columbia, 20007-2197, United States

Location

Pfizer Investigational Site

Washington D.C., District of Columbia, 20007, United States

Location

Pfizer Investigational Site

Marrero, Louisiana, 70072, United States

Location

Pfizer Investigational Site

Metairie, Louisiana, 70006, United States

Location

Pfizer Investigational Site

City of Saint Peters, Missouri, 63376, United States

Location

Pfizer Investigational Site

Creve Coeur, Missouri, 63141, United States

Location

Pfizer Investigational Site

St Louis, Missouri, 63110-1094, United States

Location

Pfizer Investigational Site

St Louis, Missouri, 63110, United States

Location

Pfizer Investigational Site

Morristown, New Jersey, 07962, United States

Location

Pfizer Investigational Site

Hickory, North Carolina, 28602, United States

Location

Pfizer Investigational Site

Kernersville, North Carolina, 27284, United States

Location

Pfizer Investigational Site

Lenoir, North Carolina, 28645, United States

Location

Pfizer Investigational Site

Lexington, North Carolina, 27295, United States

Location

Pfizer Investigational Site

Mount Airy, North Carolina, 27030, United States

Location

Pfizer Investigational Site

North Wilkesboro, North Carolina, 28659, United States

Location

Pfizer Investigational Site

Winston-Salem, North Carolina, 27103, United States

Location

Pfizer Investigational Site

Beaverton, Oregon, 97006, United States

Location

Pfizer Investigational Site

Gresham, Oregon, 97030, United States

Location

Pfizer Investigational Site

Portland, Oregon, 97210, United States

Location

Pfizer Investigational Site

Portland, Oregon, 97239, United States

Location

Pfizer Investigational Site

Tualatin, Oregon, 97062, United States

Location

Pfizer Investigational Site

West Reading, Pennsylvania, 19611, United States

Location

Pfizer Investigational Site

Christiansburg, Virginia, 24074, United States

Location

Pfizer Investigational Site

Low Moor, Virginia, 24457, United States

Location

Pfizer Investigational Site

Roanoke, Virginia, 24014, United States

Location

Pfizer Investigational Site

Salem, Virginia, 24153, United States

Location

Pfizer Investigational Site

Wytheville, Virginia, 24382, United States

Location

Pfizer Investigational Site

Everett, Washington, 98201, United States

Location

Pfizer Investigational Site

Federal Way, Washington, 98003, United States

Location

Pfizer Investigational Site

Gig Harbor, Washington, 98332, United States

Location

Pfizer Investigational Site

Kennewick, Washington, 99336, United States

Location

Pfizer Investigational Site

Lakewood, Washington, 98499, United States

Location

Pfizer Investigational Site

Puyallup, Washington, 98372, United States

Location

Pfizer Investigational Site

Tacoma, Washington, 98405, United States

Location

Pfizer Investigational Site

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Pfizer Investigational Site

Oshawa, Ontario, L1G 2B9, Canada

Location

Pfizer Investigational Site

Lévis, Quebec, G6V 3Z1, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H4J 1C5, Canada

Location

Pfizer Investigational Site

Budapest, 1125, Hungary

Location

Pfizer Investigational Site

Debrecen, 4032, Hungary

Location

Pfizer Investigational Site

Deszk, 6772, Hungary

Location

Pfizer Investigational Site

Farkasgyepű, 8582, Hungary

Location

Pfizer Investigational Site

Törökbálint, 2045, Hungary

Location

Pfizer Investigational Site

Barcelona, Barcelona, 08025, Spain

Location

Pfizer Investigational Site

Barcelona, Barcelona, 08036, Spain

Location

Pfizer Investigational Site

Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, 35016, Spain

Location

Pfizer Investigational Site

Madrid, Madrid, 28041, Spain

Location

Pfizer Investigational Site

Málaga, Malaga, 29010, Spain

Location

Pfizer Investigational Site

Seville, Sevilla, 41009, Spain

Location

Pfizer Investigational Site

Seville, Sevilla, 41013, Spain

Location

Pfizer Investigational Site

Valencia, Valencia, 46026, Spain

Location

Related Links

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

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

figitumumab; Cisplatin; Carboplatin; Etoposide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Limitations and Caveats

The study was terminated prematurely due to low participants enrollment and the halting of the figitumumab development program. The only endpoint analyzed was safety and tolerability of figitumumab ± cisplatin (or carboplatin) and etoposide.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2009
• First Posted: September 15, 2009
• Study Start: April 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: February 25, 2013
• Results First Posted: February 25, 2013

Record last verified: 2013-01

Locations

ES (8); CA (4); HU (5); US (34)