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

NCT00673049

Last updated date
Study Location
Pfizer Investigational Site
Fort Smith, Arkansas, 72903, United States
Contact
1-800-718-1021

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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.

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Large Cell Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Carcinoma, Adenosquamous Cell CarcinomaTrial Of CP-751, 871 And Erlotinib In Refractory Lung Cancer
NCT00673049
  1. Fort Smith, Arkansas
  2. Hot Springs, Arkansas
  3. Lakeport, California
  4. Orange, California
  5. Orange, California
  6. Petaluma, California
  7. Santa Rosa, California
  8. Thousand Oaks, California
  9. Westlake Valley, California
  10. Denver, Colorado
  11. Lafayette, Colorado
  12. Hollywood, Florida
  13. Lake City, Florida
  14. Lake City, Florida
  15. Pembroke Pines, Florida
  16. Alpharetta, Georgia
  17. Atlanta, Georgia
  18. Atlanta, Georgia
  19. Atlanta, Georgia
  20. Conyers, Georgia
  21. Cumming, Georgia
  22. Decatur, Georgia
  23. Duluth, Georgia
  24. Lake Spivey, Georgia
  25. Lawrenceville, Georgia
  26. Snellville, Georgia
  27. Bloomington, Illinois
  28. Peoria, Illinois
  29. Beech Grove, Indiana
  30. Indianapolis, Indiana
  31. Indianapolis, Indiana
  32. Cedar Rapids, Iowa
  33. Waterloo, Iowa
  34. Louisville, Kentucky
  35. Bethesda, Maryland
  36. New Albany, Mississippi
  37. Billings, Montana
  38. Butte, Montana
  39. Lebanon, New Hampshire
  40. Manchester, New Hampshire
  41. Amherst, New York
  42. Bronx, New York
  43. Bronx, New York
  44. Buffalo, New York
  45. Lake Success, New York
  46. Manhasset, New York
  47. New Hyde Park, New York
  48. Columbus, Ohio
  49. Columbus, Ohio
  50. Norman, Oklahoma
  51. Oklahoma City, Oklahoma
  52. Oklahoma City, Oklahoma
  53. Oklahoma City, Oklahoma
  54. Tulsa, Oklahoma
  55. Tulsa, Oklahoma
  56. Tulsa, Oklahoma
  57. Philadelphia, Pennsylvania
  58. Philadelphia, Pennsylvania
  59. Germantown, Tennessee
  60. San Antonio, Texas
  61. Charlottesville, Virginia
  62. Charlottesville, Virginia
  63. Gloucester, Virginia
  64. Glouster, Virginia
  65. Newport News, Virginia
  66. Williamsburg, Virginia
  67. Wenatchee, Washington
  68. Wheeling, West Virginia
  69. Cody, Wyoming
  70. Brasschaat,
  71. Mons,
  72. Rio de Janeiro, RJ
  73. Rio de Janeiro, RJ
  74. Porto Alegre, RS
  75. Higienopolis, Sao Paulo/ Brazil
  76. Santo André, SP
  77. Sao Paulo, SP
  78. Sao Paulo, SP
  79. São Paulo, SP
  80. Sofia,
  81. Sofia,
  82. Sofia,
  83. Varna,
  84. Toronto, Ontario
  85. Montreal, Quebec
  86. Independencia, Santiago, RM
  87. Kutna Hora,
  88. Nova Ves pod Plesi,
  89. Praha 8,
  90. Tabor,
  91. Rennes, Cedex 9
  92. BREST Cedex,
  93. La Tronche,
  94. Lille,
  95. Marseille Cedex 09,
  96. Marseille Cedex 20,
  97. Saint Pierre la Réunion Cedex,
  98. St Priest En Jarez Cedex,
  99. Villejuif,
  100. Heraklion, Crete
  101. Larisa,
  102. Budapest,
  103. Matrahaza,
  104. Szekesfehervar,
  105. Jakarta, DKI Jakarta
  106. Surabaya, East Java
  107. Cork,
  108. Dublin 24,
  109. Dublin,
  110. Avellino,
  111. Aviano (PN),
  112. Cattolica (RN),
  113. Modena,
  114. Orbassano (TO),
  115. Padova,
  116. Rimini,
  117. Roma,
  118. Gyeonggi-do,
  119. Seoul,
  120. Seoul,
  121. Riga,
  122. Riga,
  123. Bydgoszcz,
  124. Gdansk,
  125. Krakow,
  126. Krakow,
  127. Lublin,
  128. Olsztyn,
  129. Olsztyn,
  130. Rybnik,
  131. Wodzislaw Sl.,
  132. Ponce,
  133. Cluj-Napoca, Cluj
  134. Cluj-Napoca,
  135. Iasi,
  136. Krasnodar,
  137. Moscow,
  138. Moscow,
  139. Sochi,
  140. St-Petersburg,
  141. St. Petersburg,
  142. Belgrade,
  143. Sremska Kamenica,
  144. Ljubljana,
  145. Bloemfontein,
  146. Cape Town,
  147. Elche, Alicante
  148. Oviedo, Asturias
  149. L'hospitalet de Llobregat, Barcelona
  150. Manresa, Barcelona
  151. Sabadell, Barcelona
  152. Barcelona,
  153. Girona,
  154. Madrid,
  155. Madrid,
  156. Madrid,
  157. Sevilla,
  158. Sevilla,
  159. Basel,
  160. Basel,
  161. CH-4101 Bruderholz,
  162. Chur,
  163. Liestal,
  164. Taichung,
  165. Taipei,
  166. Taoyuan County,
  167. Dnipropetrovsk,
  168. Donetsk,
  169. Kharkiv,
  170. Kyiv,
  171. Sumy,
  172. Sutton, Surrey
  173. London,
  174. London,
  175. Manchester,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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 Summary The 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 Date March 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 Countries Argentina
 
Administrative Information
NCT Number  ICMJE NCT00673049
Other Study ID Numbers  ICMJE A4021018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP