Randomized Ph 2 Trial Of Paclitaxel/Carboplatin /Bevacizumab + PF-3512676 And P/C/B Alone In Advanced Nonsquamous NSCLC

September 24, 2009 updated by: Pfizer

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

23

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Bessemer, Alabama, United States, 35022
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35209
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35205
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35213
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35235
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 32511
        • Pfizer Investigational Site
      • Mobile, Alabama, United States, 36607
        • Pfizer Investigational Site
    • California
      • Fountain Valley, California, United States, 92708
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90033
        • Pfizer Investigational Site
    • Florida
      • Cocoa Beach, Florida, United States, 32931
        • Pfizer Investigational Site
      • Merritt Island, Florida, United States, 32952
        • Pfizer Investigational Site
      • Rockledge, Florida, United States, 32955
        • Pfizer Investigational Site
      • Titusville, Florida, United States, 32796
        • Pfizer Investigational Site
    • Georgia
      • Valdosta, Georgia, United States, 31602
        • Pfizer Investigational Site
    • Illinois
      • Joliet, Illinois, United States, 60435
        • Pfizer Investigational Site
      • Joliet, Illinois, United States, 60432
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Pfizer Investigational Site
    • North Carolina
      • Clinton, North Carolina, United States, 28382
        • Pfizer Investigational Site
      • Goldsboro, North Carolina, United States, 27534
        • Pfizer Investigational Site
      • Pollocksville, North Carolina, United States, 28573
        • Pfizer Investigational Site
      • Wilson, North Carolina, United States, 27893
        • Pfizer Investigational Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Pfizer Investigational Site
      • Knoxville, Tennessee, United States, 37934
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, United States, 78705
        • Pfizer Investigational Site
      • Austin, Texas, United States, 78745
        • Pfizer Investigational Site
      • Austin, Texas, United States, 78759
        • Pfizer Investigational Site
      • Austin, Texas, United States, 78758
        • Pfizer Investigational Site
      • Georgetown, Texas, United States, 78626
        • Pfizer Investigational Site
      • San Marcos, Texas, United States, 78666
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: B
Standard of care chemotherapy
Drug: paclitaxel + carboplatin + bevacizumab
paclitaxel 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles
Other Names:
  • Taxol; Paraplatin
Experimental: A
Standard of care chemotherapy plus experimental intervention (PF-3512676)
Drug: carboplatin + paclitaxel + bevacizumab + PF-3512676
carboplatin AUC 6 intravenously on Day 1 of each 21 day cycle x 6 cycles
Other Names:
  • Paraplatin; Taxol; Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: 110 Events
110 Events

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: Time of death
Time of death
Time to Tumor Progression
Time Frame: End of treatment
End of treatment
Overall Objective Response Rate
Time Frame: Time of progressive disease
Time of progressive disease
Duration of Response
Time Frame: Time of progression
Time of progression
Overall safety profile
Time Frame: 28 days post treatment
28 days post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

April 10, 2006

First Submitted That Met QC Criteria

April 10, 2006

First Posted (Estimate)

April 12, 2006

Study Record Updates

Last Update Posted (Estimate)

September 28, 2009

Last Update Submitted That Met QC Criteria

September 24, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A8501003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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