A Randomized Phase 2 Trial Of Paclitaxel, Carboplatin And Bevacizumab With Or Without PF-3512676 As First-Line Treatment Of Patients With Advanced Nonsquamous Non-Small Cell Lung Cancer
18 Years
N/A
Both
Carcinoma, Non-Small-Cell Lung
Trial Information
A Randomized Phase 2 Trial Of Paclitaxel, Carboplatin And Bevacizumab With Or Without PF-3512676 As First-Line Treatment Of Patients With Advanced 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.
Inclusion Criteria:
- Advanced Stage IIIb with pleural effusion or Stage IV nonsquamous non-small cell lung
cancer
- ECOG Performance Status 0-1
- Measurable disease per RECIST criteria
Exclusion Criteria:
- Squamous cell, small cell, or carcinoid lung cancer
- CNS metastasis
- Pre-existing autoimmune or antibody mediated disease
- Prior systemic treatment for NSCLC with chemo, immunotherapy, biologics, or
investigation drugs
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:
Progression-free survival
Outcome Time Frame:
110 Events
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:
A8501003
NCT ID:
NCT00313768
Start Date:
December 2005
Completion Date:
May 2008
Related Keywords:
- Carcinoma, Non-Small-Cell Lung
- advanced carcinoma, non-small cell lung, Phase II, paclitaxel, Taxol, carboplatin, Paraplatin, bevacizumab, Avastin, PF-3512676, immunotherapy, immunomodulator
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
Name | Location |
|---|---|
| Pfizer Investigational Site | Birmingham, Alabama 35205 |
| Pfizer Investigational Site | Blendora, California 91740 |
| Pfizer Investigational Site | Atlanta, Georgia 30342 |
| Pfizer Investigational Site | Springfield, Illinois 62701-1014 |
| Pfizer Investigational Site | Houston, Texas 77030 |
| Pfizer Investigational Site | Clearwater, Florida 33761 |
| Pfizer Investigational Site | Westminster, Maryland 21157 |
| Pfizer Investigational Site | Asheville, North Carolina 28801 |
| Pfizer Investigational Site | Bristol, Tennessee 37620 |
