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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Carcinoma, Squamous Cell, Carcinoma, Adenosquamous, Carcinoma, Large Cell, Carcinoma, Non-Small-Cell Lung

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival (OS)

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A4021016

NCT ID:

NCT00596830

Start Date:

April 2008

Completion Date:

September 2012

Related Keywords:

  • Carcinoma, Squamous Cell
  • Carcinoma, Adenosquamous
  • Carcinoma, Large Cell
  • Carcinoma, Non-Small-Cell Lung
  • IGF-1R inhibitor
  • Non-small-cell lung carcinoma
  • CP-751
  • 871
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Squamous Cell
  • Carcinoma, Adenosquamous
  • Carcinoma, Large Cell

Name

Location

Pfizer Investigational SiteBirmingham, Alabama  35205
Pfizer Investigational SiteAtlanta, Georgia  30342
Pfizer Investigational SiteCrestview Hills, Kentucky  41017
Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteRochester, Minnesota  55905
Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteRichmond, Virginia  23249
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteFlagstaff, Arizona  86001
Pfizer Investigational SiteNorth Little Rock, Arkansas  72117
Pfizer Investigational SiteAurora, Colorado  80012
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteCarmel, Indiana  46032
Pfizer Investigational SiteCedar Rapids, Iowa  52403
Pfizer Investigational SiteKansas City, Kansas  66112
Pfizer Investigational SiteWestminster, Maryland  21157
Pfizer Investigational SiteNorth Adams, Massachusetts  01247
Pfizer Investigational SiteColumbia, Missouri  65201
Pfizer Investigational SiteLas Vegas, Nevada  89128
Pfizer Investigational SiteAsheville, North Carolina  28801
Pfizer Investigational SiteBartlesville, Oklahoma  74006
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteEasley,, South Carolina  29640
Pfizer Investigational SiteFarmington, Connecticut  06030-3805
Pfizer Investigational SiteOmaha, Nebraska  68198
Pfizer Investigational SiteBristol, Tennessee  37620
Pfizer Investigational SiteOlive Branch, Mississippi  38654
Pfizer Investigational SiteSalt Lake City, Utah  84112
Pfizer Investigational SiteLebanon, New Hampshire  03766
Pfizer Investigational SiteLewistown, Idaho  83501