To assess the efficacy and safety of PF-3512676 administered in combination with pemetrexed for the treatment of patients with locally advanced or metastatic NSCLC who have failed one prior chemotherapy regimen
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 and protocol follow-up. Data collection was completed on 31 January 2008.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
500 mg/m2 intravenously Day 1 of each 21 day cycle until disease progression or unacceptable toxicity
pemetrexed 500 mg/m2 intravenously Day 1 of each 21 day cycle until disease progression or unacceptable toxicity
Pfizer Investigational Site
Litchfield Park, Arizona, United States
Pfizer Investigational Site
Progression-free survival
Time frame: 110 Events
Overall Survival
Time frame: Time of death
Overall Safety Profile
Time frame: 28 days post treatment
Patient Reported Outcome
Time frame: End of Treatment
Time to Tumor Progression
Time frame: End of treatment
Overall Objective Response Rate
Time frame: Time of disease progressive disease
Duration of Response
Time frame: Time of disease progression
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Sun City, Arizona, United States
Pfizer Investigational Site
Bentonville, Arkansas, United States
Pfizer Investigational Site
Fayetteville, Arkansas, United States
Pfizer Investigational Site
Hudson, Florida, United States
Pfizer Investigational Site
New Port Richey, Florida, United States
Pfizer Investigational Site
Mahwah, New Jersey, United States
Pfizer Investigational Site
Midland Park, New Jersey, United States
Pfizer Investigational Site
Paramus, New Jersey, United States
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Westwood, New Jersey, United States
...and 10 more locations