Carboplatin And Paclitaxel With Or Without CP-751, 871 (An IGF-1R Inhibitor) For Advanced NSCLC Of Squamous, Large Cell And Adenosquamous Carcinoma Histology

NCT00596830

Last updated date
Study Location
Pfizer Investigational Site
Florence, Alabama, 35630, 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.
Squamous Cell Carcinoma, Adenosquamous Carcinoma, Large Cell Carcinoma, Non-Small-Cell Lung 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

- Confirmed diagnosis of non small cell lung cancer with a primary histology of predominantly squamous cell, large cell or adenosquamous carcinoma.

- Advanced NSCLC with documented Stage IIIB (with pleural effusion) or Stage IV or recurrent disease.

- No prior systemic treatment for NSCLC, except for adjuvant chemotherapy. Adjuvant chemotherapy must have completed for greater than or equal to 12 months prior to randomization.

- Prior surgery or radiation therapy is permitted if completed at least 3 weeks prior to randomization and all acute toxicities have resolved.

- ECOG performance status (PS) 0 or 1.

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


- Patients with symptomatic central nervous system (CNS) metastases are not permitted.


- Patients requiring chronic steroid use or patients with uncontrolled diabetes are not
permitted.


- Patients with other active cancer types are not permitted.

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Squamous Cell Carcinoma, Adenosquamous Carcinoma, Large Cell Carcinoma, Non-Small-Cell Lung CarcinomaCarboplatin And Paclitaxel With Or Without CP-751, 871 (An IGF-1R Inhibitor) For Advanced NSCLC Of Squamous, Large Cell And Adenosquamous Carcinoma Histology
NCT00596830
  1. Florence, Alabama
  2. Huntsville, Alabama
  3. Muscle Shoals, Alabama
  4. Phoenix, Arizona
  5. Scottsdale, Arizona
  6. Hot Springs, Arkansas
  7. Aurora, Colorado
  8. Boulder, Colorado
  9. Colorado Springs, Colorado
  10. Colorado Springs, Colorado
  11. Denver, Colorado
  12. Denver, Colorado
  13. Lakewood, Colorado
  14. Littleton, Colorado
  15. Lone Tree, Colorado
  16. Longmont, Colorado
  17. Parker, Colorado
  18. Thornton, Colorado
  19. Norwalk, Connecticut
  20. Norwich, Connecticut
  21. Hudson, Florida
  22. Jacksonville, Florida
  23. Lake City, Florida
  24. Lake City, Florida
  25. Miramar Beach, Florida
  26. New Port Richey, Florida
  27. Orlando, Florida
  28. Orlando, Florida
  29. Pensacola, Florida
  30. Pensacola, Florida
  31. Port St. Lucie, Florida
  32. Spring Hill, Florida
  33. Alpharetta, Georgia
  34. Atlanta, Georgia
  35. Atlanta, Georgia
  36. Atlanta, Georgia
  37. Conyers, Georgia
  38. Cumming, Georgia
  39. Decatur, Georgia
  40. Duluth, Georgia
  41. Lake Spivey, Georgia
  42. Lawrenceville, Georgia
  43. Macon, Georgia
  44. Marietta, Georgia
  45. Snellville, Georgia
  46. Coeur d' Alene, Idaho
  47. Arlington Heights, Illinois
  48. Aurora, Illinois
  49. Chicago, Illinois
  50. Elk Grove Village, Illinois
  51. Galesburg, Illinois
  52. Winfield, Illinois
  53. Yorkville, Illinois
  54. Avon, Indiana
  55. Beech Grove, Indiana
  56. Hobart, Indiana
  57. Hobart, Indiana
  58. Indianapolis, Indiana
  59. Indianapolis, Indiana
  60. Mooresville, Indiana
  61. Mooresville, Indiana
  62. Munster, Indiana
  63. Cedar Rapids, Iowa
  64. Kansas City, Kansas
  65. Overland Park, Kansas
  66. Shawnee Mission, Kansas
  67. Louisville, Kentucky
  68. Louisville, Kentucky
  69. Baltimore, Maryland
  70. Baltimore, Maryland
  71. Lawrence, Massachusetts
  72. Quincy, Massachusetts
  73. Stoneham, Massachusetts
  74. Weymouth, Massachusetts
  75. Worcester, Massachusetts
  76. Detroit, Michigan
  77. Farmington Hills, Michigan
  78. St. Joseph, Michigan
  79. St. Louis Park, Minnesota
  80. Columbus, Mississippi
  81. Corinth, Mississippi
  82. Oxford, Mississippi
  83. Southaven, Mississippi
  84. Tupelo, Mississippi
  85. Kansas City, Missouri
  86. Kansas City, Missouri
  87. Lee's Summit, Missouri
  88. Lincoln, Nebraska
  89. Lincoln, Nebraska
  90. Lincoln, Nebraska
  91. Las Vegas, Nevada
  92. Las Vegas, Nevada
  93. Lebanon, New Hampshire
  94. Manchester, New Hampshire
  95. Lake Success, New York
  96. Manhasset, New York
  97. New Hyde Park, New York
  98. Oneida, New York
  99. Oswego, New York
  100. Syracuse, New York
  101. Syracuse, New York
  102. Burlington, North Carolina
  103. Canton, Ohio
  104. Cleveland, Ohio
  105. Dover, Ohio
  106. Tulsa, Oklahoma
  107. Tulsa, Oklahoma
  108. Tulsa, Oklahoma
  109. Clairton, Pennsylvania
  110. Greensburg, Pennsylvania
  111. Johnstown, Pennsylvania
  112. McKeesport, Pennsylvania
  113. Philadelphia, Pennsylvania
  114. Philadelphia, Pennsylvania
  115. Pittsburgh, Pennsylvania
  116. Pittsburgh, Pennsylvania
  117. Pittsburgh, Pennsylvania
  118. Radnor, Pennsylvania
  119. Sayre, Pennsylvania
  120. Wexford, Pennsylvania
  121. Columbia, South Carolina
  122. Sumter, South Carolina
  123. Bartlett, Tennessee
  124. Knoxville, Tennessee
  125. Knoxville, Tennessee
  126. Knoxville, Tennessee
  127. Maryville, Tennessee
  128. Memphis, Tennessee
  129. Memphis, Tennessee
  130. Austin, Texas
  131. Austin, Texas
  132. Austin, Texas
  133. Austin, Texas
  134. Dallas, Texas
  135. Fort Sam Houston, Texas
  136. Fort Worth, Texas
  137. Fort Worth, Texas
  138. Grapevine, Texas
  139. Houston, Texas
  140. Irving, Texas
  141. Longview, Texas
  142. Plano, Texas
  143. Round Rock, Texas
  144. Round Rock, Texas
  145. San Antonio, Texas
  146. San Marcos, Texas
  147. Tyler, Texas
  148. Bountiful, Utah
  149. Layton, Utah
  150. Murray, Utah
  151. Provo, Utah
  152. Salt Lake City, Utah
  153. Salt Lake City, Utah
  154. West Valley City, Utah
  155. Arlington, Virginia
  156. Christiansburg, Virginia
  157. Fairfax, Virginia
  158. Gainesville, Virginia
  159. Leesburg, Virginia
  160. Roanoke, Virginia
  161. Salem, Virginia
  162. Winchester, Virginia
  163. Woodbridge, Virginia
  164. Wytheville, Virginia
  165. Seattle, Washington
  166. Seattle, Washington
  167. Spokane Valley, Washington
  168. Spokane, Washington
  169. Spokane, Washington
  170. Albury, New South Wales
  171. Port Macquarie, New South Wales
  172. Geelong, Victoria
  173. Wodonga, Victoria
  174. Linz,
  175. Wien,
  176. Rio de Janeiro, RJ
  177. Rio de Janeiro, RJ
  178. Higienopolis, Sao Paulo/ Brazil
  179. Sao Paulo, SP
  180. Sao Paulo, SP
  181. Sao Paulo, SP
  182. Sofia,
  183. Sofia,
  184. Sofia,
  185. Varna,
  186. Edmonton, Alberta
  187. Levis, Quebec
  188. Nova Ves pod Plesi,
  189. Praha 8,
  190. Pribram I,
  191. Pribram V,
  192. Helsinki,
  193. Pori,
  194. Caen Cedex 05,
  195. Caen Cedex,
  196. Clermond-Ferrand Cedex 01,
  197. Dijon,
  198. Lyon Cedex 04,
  199. Nantes Cedex 2,
  200. Rennes Cedex 9,
  201. Saint Herblain Cedex,
  202. Saint Pierre la Réunion Cedex,
  203. Grosshansdorf,
  204. Karlsruhe,
  205. Leipzig,
  206. Mainz,
  207. Oldenburg,
  208. Thessaloniki, Pylaia
  209. Athens,
  210. Athens,
  211. Thessaloniki,
  212. Kowloon,
  213. Shatin, New Territories,
  214. Tuen Mun,
  215. Budapest,
  216. Deszk,
  217. Szekesfehervar,
  218. Szombathely,
  219. Torokbalint,
  220. Navrangpura / Ahmedabad, Gujarat
  221. Bangalore, Karnataka
  222. Mumbai, Maharashtra
  223. Nagpur, Maharashtra
  224. New Delhi,
  225. Genova,
  226. Orbassano (TO),
  227. Padova,
  228. Roma,
  229. Kashiwa, Chiba
  230. Matsuyama-shi, Ehime
  231. Gifu-shi, Gifu
  232. Sapporo-shi, Hokkaido
  233. Akashi, Hyogo
  234. Yokohama-city, Kanagawa
  235. Sakai-shi, Osaka-fu
  236. Osaka-city, Osaka
  237. Osakasayama-shi, Osaka
  238. Chuo-Ku, Tokyo
  239. Tokyo,
  240. Gyeonggi-do,
  241. Seoul,
  242. Seoul,
  243. Seoul,
  244. Gdansk,
  245. Krakow,
  246. Siedlce,
  247. Warszawa,
  248. Warszawa,
  249. Warszawa,
  250. Wroclaw,
  251. Ponce,
  252. Moscow,
  253. Moscow,
  254. Saint-Petersburg,
  255. Samara,
  256. Sochi,
  257. St-Petersburg,
  258. St. Petersburg,
  259. Nitra-Zobor,
  260. Nove Zamky,
  261. Poprad,
  262. L'hospitalet de Llobregat, Barcelona
  263. Santander, Cantabria
  264. Pamplona, Navarra
  265. Cordoba,
  266. Madrid,
  267. Valencia,
  268. Fribourg,
  269. Zuerich,
  270. Niao Sung Hsiang, Kaohsiung Hsien
  271. Tainan,
  272. Taipei,
  273. Taipei,
  274. Adana,
  275. Ankara,
  276. Dnipropetrovsk,
  277. Donetsk,
  278. Kyiv,
  279. Lviv,
  280. Sumy,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Carboplatin And Paclitaxel With Or Without CP-751, 871 (An IGF-1R Inhibitor) For Advanced NSCLC Of Squamous, Large Cell And Adenosquamous Carcinoma Histology
Official Title  ICMJE Randomized, Open Label, Phase III Trial Of CP- 751,871 In Combination With Paclitaxel And Carboplatin Versus Paclitaxel And Carboplatin In Patients With Non Small Cell Lung Cancer
Brief Summary Determine whether the addition of CP- 751,871 in combination with paclitaxel plus carboplatin prolongs survival in patients with locally advanced (Stage IIIB with pleural effusion) or metastatic (Stage IV or recurrent) NSCLC of non adenocarcinoma histology.
Detailed Description The study was discontinued on December 29, 2009 due to an analysis by an independent Data Safety Monitoring Committee indicating that the addition of CP-751,871 [figitumumab] to paclitaxel plus carboplatin would be unlikely to meet the primary endpoint of improving overall survival compared to paclitaxel plus carboplatin alone. The DSMC recommendation to terminate the trial was based on futility, not on specific safety concerns; however, the DSMC recommended to investigate hyperglycemia as a potential contributor to the morbidity of the patients.
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, Squamous Cell
  • Carcinoma, Adenosquamous
  • Carcinoma, Large Cell
  • Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • Drug: CP-751,871 (Figitumumab)
    CP 751,871 is a potent and selective fully human monoclonal antibody against the insulin like growth factor 1 receptor (IGF-1R). Patients in Arm A will receive CP-751, 871 intravenously every 21 days for up to six cycles.
  • Drug: Carboplatin
    Carboplatin is a standard chemotherapeutic agent used in patients with lung cancer. Patients in Arm A will receive carboplatin intravenously every 21 days for up to six cycles.
  • Drug: Paclitaxel
    Paclitaxel is a standard chemotherapeutic agent used in patients with lung cancer. Patients in Arm A will receive paclitaxel intravenously every 21 days for up to six cycles.
  • Drug: Carboplatin
    Carboplatin is a standard chemotherapeutic agent used in patients with lung cancer. Patient in Arm B will receive carboplatin intravenously every 21 days for up to six cycles.
  • Drug: Paclitaxel
    Paclitaxel is a standard chemotherapeutic agent used in patients with lung cancer. Patient in Arm B will receive paclitaxel intravenously every 21 days for up to six cycles.
Study Arms  ICMJE
  • Experimental: A
    Patients in Arm A will receive CP-751, 871 in combination with paclitaxel and carboplatin intravenously every 21 days for up to six cycles.`
    Interventions:
    • Drug: CP-751,871 (Figitumumab)
    • Drug: Carboplatin
    • Drug: Paclitaxel
  • Active Comparator: B
    Patient in Arm B will receive paclitaxel and carboplatin intravenously every 21 days for up to six cycles.
    Interventions:
    • Drug: Carboplatin
    • Drug: Paclitaxel
Publications * Langer CJ, Novello S, Park K, Krzakowski M, Karp DD, Mok T, Benner RJ, Scranton JR, Olszanski AJ, Jassem J. Randomized, phase III trial of first-line figitumumab in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone in patients with advanced non-small-cell lung cancer. J Clin Oncol. 2014 Jul 1;32(19):2059-66. doi: 10.1200/JCO.2013.54.4932. Epub 2014 Jun 2.

*   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: June 17, 2011)
681
Original Estimated Enrollment  ICMJE
 (submitted: January 8, 2008)
820
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Confirmed diagnosis of non small cell lung cancer with a primary histology of predominantly squamous cell, large cell or adenosquamous carcinoma.
  • Advanced NSCLC with documented Stage IIIB (with pleural effusion) or Stage IV or recurrent disease.
  • No prior systemic treatment for NSCLC, except for adjuvant chemotherapy. Adjuvant chemotherapy must have completed for greater than or equal to 12 months prior to randomization.
  • Prior surgery or radiation therapy is permitted if completed at least 3 weeks prior to randomization and all acute toxicities have resolved.
  • ECOG performance status (PS) 0 or 1.

Exclusion Criteria:

  • Patients with symptomatic central nervous system (CNS) metastases are not permitted.
  • Patients requiring chronic steroid use or patients with uncontrolled diabetes are not permitted.
  • Patients with other active cancer types are not permitted.
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 Australia,   Austria,   Brazil,   Bulgaria,   Canada,   Czech Republic,   Finland,   France,   Germany,   Greece,   Hong Kong,   Hungary,   India,   Italy,   Japan,   Korea, Republic of,   Poland,   Puerto Rico,   Russian Federation,   Slovakia,   Spain,   Switzerland,   Taiwan,   Turkey,   Ukraine,   United States
Removed Location Countries Ireland
 
Administrative Information
NCT Number  ICMJE NCT00596830
Other Study ID Numbers  ICMJE A4021016
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 December 2013

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