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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

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Washington, District of Columbia, 20007-2197 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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%

NCT00977561
Pfizer
Terminated
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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A Study Of Cisplatin (Or Carboplatin) And Etoposide With Or Without Figitumumab (CP-751,871) In Patients With Extensive-Stage Small Cell Lung Cancer
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
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Small Cell Lung Carcinoma
  • 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)
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
October 2011
October 2011   (Final data collection date for primary outcome measure)

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%
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Hungary,   Spain,   United States
Bulgaria
 
NCT00977561
A4021032
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2013

ICMJE     Data element required by the

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

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