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

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NCT00977561

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Study Location
Pfizer Investigational Site
Washington, District of Columbia, 20007-2197, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
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

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


- Any prior systemic therapy for Small Cell Lung Cancer (SCLC)


- HbA1c > or = 5.7%

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Small Cell Lung CarcinomaA Study Of Cisplatin (Or Carboplatin) And Etoposide With Or Without Figitumumab (CP-751,871) In Patients With Extensive-Stage Small Cell Lung Cancer
NCT00977561
  1. Washington, District of Columbia
  2. Washington, District of Columbia
  3. Marrero, Louisiana
  4. Metairie, Louisiana
  5. Creve Coeur, Missouri
  6. St. Louis, Missouri
  7. St. Louis, Missouri
  8. St. Peters, Missouri
  9. Morristown, New Jersey
  10. Hickory, North Carolina
  11. Kernersville, North Carolina
  12. Lenoir, North Carolina
  13. Lexington, North Carolina
  14. Mount Airy, North Carolina
  15. North Wilkesboro, North Carolina
  16. Winston-Salem, North Carolina
  17. Beaverton, Oregon
  18. Gresham, Oregon
  19. Portland, Oregon
  20. Portland, Oregon
  21. Tualatin, Oregon
  22. West Reading, Pennsylvania
  23. Christiansburg, Virginia
  24. Low Moor, Virginia
  25. Roanoke, Virginia
  26. Salem, Virginia
  27. Wytheville, Virginia
  28. Everett, Washington
  29. Federal Way, Washington
  30. Gig Harbor, Washington
  31. Kennewick, Washington
  32. Lakewood, Washington
  33. Puyallup, Washington
  34. Tacoma, Washington
  35. Oshawa, Ontario
  36. Sudbury, Ontario
  37. Levis, Quebec
  38. Montreal, Quebec
  39. Budapest,
  40. Debrecen,
  41. Deszk,
  42. Farkasgyepu,
  43. Torokbalint,
  44. Barcelona,
  45. Barcelona,
  46. Las Palmas de Gran Canaria,
  47. Madrid,
  48. Malaga,
  49. Sevilla,
  50. Sevilla,
  51. Valencia,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of Cisplatin (Or Carboplatin) And Etoposide With Or Without Figitumumab (CP-751,871) In Patients With Extensive-Stage Small Cell Lung Cancer
Official Title  ICMJE A Phase 2, Randomized, Open Label Study Of Figitumumab (CP-751,871) Plus Cisplatin (Or Carboplatin) And Etoposide, Versus Cisplatin (Or Carboplatin) And Etoposide Alone, As First Line Treatment In Patients With Extensive Stage Disease Small Cell Lung Cancer
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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Small Cell Lung Carcinoma
Intervention  ICMJE
  • Drug: figitumumab
    Figitumumab (20 mg/kg)
  • Drug: Cisplatin (Or Carboplatin)
    Cisplatin (75 mg/m2 IV on Day 1) or Carboplatin AUC 5
  • Drug: Etoposide
    Etoposide (100 mg/m2 IV on Days 1, 2 and 3)
Study Arms  ICMJE
  • Experimental: Arm A
    Figitumumab (CP-751,871) Plus Chemotherapy [Cisplatin (Or Carboplatin) And Etoposide] All drugs to be administered on a 21 day cycle
    Interventions:
    • Drug: figitumumab
    • Drug: Cisplatin (Or Carboplatin)
    • Drug: Etoposide
  • Active Comparator: Arm B
    Chemotherapy [Cisplatin (Or Carboplatin) And Etoposide] All drugs to be administered on a 21 day cycle
    Interventions:
    • Drug: Cisplatin (Or Carboplatin)
    • Drug: Etoposide
Publications * Not Provided

*   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: March 18, 2011)		9
Original Estimated Enrollment  ICMJE
 (submitted: September 14, 2009)		120
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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%
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 Canada,   Hungary,   Spain,   United States
Removed Location Countries Bulgaria
 
Administrative Information
NCT Number  ICMJE NCT00977561
Other Study ID Numbers  ICMJE A4021032
Has Data Monitoring Committee No
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 January 2013

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