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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung

Thank you

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 SiteBirmingham, Alabama  35205
Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteAtlanta, Georgia  30342
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteWestminster, Maryland  21157
Pfizer Investigational SiteAsheville, North Carolina  28801
Pfizer Investigational SiteBristol, Tennessee  37620