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Trial Of CP-751, 871 And Erlotinib In Refractory Lung Cancer

Last updated on November 11, 2019

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Study Location
Pfizer Investigational Site
Fort Smith, Arkansas, 72903 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Large Cell Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Carcinoma, Adenosquamous Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Non small cell lung cancer with a primary histology of squamous cell, large cell or
adenosquamous carcinoma. At least 1 measurable lesion, as defined by RECIST.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Primary NSCLC adenocarcinoma and its subtypes or unknown/unspecified histology.

- Prior Erlotinib therapy.

- Prior anti IGF IR based investigational therapy.

NCT00673049
Pfizer
Terminated
Trial Of CP-751, 871 And Erlotinib In Refractory Lung Cancer

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Descriptive Information
Brief Title  ICMJE Trial Of CP-751, 871 And Erlotinib In Refractory Lung Cancer
Official Title  ICMJE Randomized, Open Label, Phase 3 Trial Of Erlotinib Alone Or In Combination With CP-751,871 In Patients With Advanced Non Small Cell Lung Cancer Of Non Adenocarcinoma Histology
Brief SummaryThe objective of this study is to test a clinical benefit of the addition of CP 751,871 to erlotinib therapy in patients with advanced NSCLC of non adenocarcinoma histology. The primary endpoint is Overall Survival (OS).
Detailed Description

This study was terminated on March 8, 2010 due to an analysis by an independent Data Safety Monitoring Committee (DSMC) indicating that the addition of CP-751,871 [figitumumab] to erlotinib [Tarceva] would be unlikely to meet the primary endpoint of improving overall survival when compared to erlotinib alone.

This Oncology study continues as terminated, however for ethical reasons some patients, noted with resultant benefit, continue receiving treatment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Carcinoma, Large Cell
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Squamous Cell
  • Carcinoma, Adenosquamous Cell
Intervention  ICMJE
  • Drug: CP 751,871 (Figitumumab)
    CP 751,871 (20 mg/kg) will be administered as an IV infusion on study Days 1 and 2 in Cycle 1, and every three weeks (from Day 1) (Cycle) thereafter.
  • Drug: Erlotinib
    Erlotinib (one tablet of 150 mg/day PO).
  • Drug: Erlotinib
    Erlotinib (one tablet of 150 mg/day PO). Erlotinib will be taken at least one hour before or two hours after the ingestion of food.
Study Arms  ICMJE
  • Experimental: Arm A

    The CP 751,871 treatment in combination with erlotinib will be given in three week cycles.

    CP 751,871 (20 mg/kg) + erlotinib (150 mg/day) CP 751,871 will be administered as an IV infusion on study Days 1 and 2 in Cycle 1, and every three weeks (from Day 1) (Cycle) thereafter.

    Interventions:
    • Drug: CP 751,871 (Figitumumab)
    • Drug: Erlotinib
  • Active Comparator: Arm B
    Erlotinib (one tablet of 150 mg/day PO). Erlotinib will be taken at least one hour before or two hours after the ingestion of food)
    Intervention: Drug: Erlotinib
Publications *Scagliotti GV, Bondarenko I, Blackhall F, Barlesi F, Hsia TC, Jassem J, Milanowski J, Popat S, Sanchez-Torres JM, Novello S, Benner RJ, Green S, Molpus K, Soria JC, Shepherd FA. Randomized, phase III trial of figitumumab in combination with erlotinib versus erlotinib alone in patients with nonadenocarcinoma nonsmall-cell lung cancer. Ann Oncol. 2015 Mar;26(3):497-504. doi: 10.1093/annonc/mdu517. Epub 2014 Nov 13.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 21, 2012)
583
Original Estimated Enrollment  ICMJE
 (submitted: May 5, 2008)
600
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion DateMarch 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Non small cell lung cancer with a primary histology of squamous cell, large cell or adenosquamous carcinoma. At least 1 measurable lesion, as defined by RECIST.

Exclusion Criteria:

  • Primary NSCLC adenocarcinoma and its subtypes or unknown/unspecified histology.
  • Prior Erlotinib therapy.
  • Prior anti IGF IR based investigational therapy.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   Czech Republic,   France,   Greece,   Hungary,   Indonesia,   Ireland,   Italy,   Korea, Republic of,   Latvia,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Serbia,   Slovenia,   South Africa,   Spain,   Switzerland,   Taiwan,   Ukraine,   United Kingdom,   United States
Removed Location CountriesArgentina
 
Administrative Information
NCT Number  ICMJE NCT00673049
Other Study ID Numbers  ICMJE A4021018
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJuly 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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