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
18 Years
N/A
Both
Carcinoma, Squamous Cell, Carcinoma, Adenosquamous, Carcinoma, Large Cell, Carcinoma, Non-Small-Cell Lung
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 |
