To assess the efficacy and safety of PF-3512676 administered in combination with paclitaxel, carboplatin and bevacizumab as first-line treatment in patients with locally advanced or metastatic nonsquamous non-small cell lung cancer
PF-3512676 dosing was stopped 21 June 2007 when Pfizer decided to stop the administration of PF-3512676 in all trials which combined PF-3512676 with cytotoxic chemotherapy. the decision was made subsequent to DSMC recommendation to close two phase III randomized trials in non-small cell lung cancer which also combined PF-3512676 with cytotoxic chemotherapy, citing lack of efficacy concerns as the primary reason with safety issues (sepsis, thrombocytopenia) also contributing to the decision. Subjects were allowed to complete standard of care treatment/survival follow-up. Data collection was completed on 22 May 2008.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
paclitaxel 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles
carboplatin AUC 6 intravenously on Day 1 of each 21 day cycle x 6 cycles
Progression-free survival
Time frame: 110 Events
Time to Tumor Progression
Time frame: End of treatment
Overall Objective Response Rate
Time frame: Time of progressive disease
Duration of Response
Time frame: Time of progression
Overall Survival
Time frame: Time of death
Overall safety profile
Time frame: 28 days post treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pfizer Investigational Site
Bessemer, Alabama, United States
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Mobile, Alabama, United States
Pfizer Investigational Site
Fountain Valley, California, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Cocoa Beach, Florida, United States
...and 19 more locations