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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

Thank you

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 Site Birmingham, Alabama  35205
Pfizer Investigational Site Atlanta, Georgia  30342
Pfizer Investigational Site Crestview Hills, Kentucky  41017
Pfizer Investigational Site Detroit, Michigan  48201
Pfizer Investigational Site Rochester, Minnesota  55905
Pfizer Investigational Site Cincinnait, Ohio  45236
Pfizer Investigational Site Springfield, Illinois  62701-1014
Pfizer Investigational Site Bronx, New York  10461
Pfizer Investigational Site Houston, Texas  77030
Pfizer Investigational Site Richmond, Virginia  23249
Pfizer Investigational Site Federal Way, Washington  98003
Pfizer Investigational Site Flagstaff, Arizona  86001
Pfizer Investigational Site North Little Rock, Arkansas  72117
Pfizer Investigational Site Aurora, Colorado  80012
Pfizer Investigational Site Clearwater, Florida  33761
Pfizer Investigational Site Carmel, Indiana  46032
Pfizer Investigational Site Cedar Rapids, Iowa  52403
Pfizer Investigational Site Kansas City, Kansas  66112
Pfizer Investigational Site Westminster, Maryland  21157
Pfizer Investigational Site North Adams, Massachusetts  01247
Pfizer Investigational Site Columbia, Missouri  65201
Pfizer Investigational Site Las Vegas, Nevada  89128
Pfizer Investigational Site Asheville, North Carolina  28801
Pfizer Investigational Site Bartlesville, Oklahoma  74006
Pfizer Investigational Site Kingston, Pennsylvania  18704-5535
Pfizer Investigational Site Easley,, South Carolina  29640
Pfizer Investigational Site Farmington, Connecticut  06030-3805
Pfizer Investigational Site Omaha, Nebraska  68198
Pfizer Investigational Site Bristol, Tennessee  37620
Pfizer Investigational Site Olive Branch, Mississippi  38654
Pfizer Investigational Site Salt Lake City, Utah  84112
Pfizer Investigational Site Lebanon, New Hampshire  03766
Pfizer Investigational Site Lewistown, Idaho  83501