Trial of Paclitaxel/Carboplatin + PF-3512676 vs Paclitaxel/Carboplatin Alone in Patients With Advanced Non-Small Cell Lung Cancer

March 10, 2015 updated by: Pfizer

International, Randomized, Open-Label, Phase 3 Trial of Paclitaxel/Carboplatin Plus PF-3512676 Versus Paclitaxel/Carboplatin Alone as First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer

To assess the efficacy and safety of PF-3512676 administered in combination with paclitaxel/carboplatin chemotherapy as first-line treatment in patients with locally advanced or metastatic Non-Small-Cell Lung Cancer (NSCLC) and to compare it to the efficacy and safety of paclitaxel

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

PF-3512676 dosing was stopped 20 June 2007 in response to DSMC recommendation to close the trial, citing lack of efficacy concerns as the primary reason with a safety issue (sepsis) also contributing to the decision. Subjects were allowed to complete standard of care treatment/survival follow-up. Data collection was completed on 17 July 2008.

Study Type

Interventional

Enrollment (Actual)

828

Phase

  • Phase 3

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

  • Australia
    • New South Wales
      • Albury, New South Wales, Australia, 2640
        • Pfizer Investigational Site
      • Camperdown, New South Wales, Australia, 2050
        • Pfizer Investigational Site
      • Randwick, New South Wales, Australia, 2031
        • Pfizer Investigational Site
    • Queensland
      • Pimlico, Queensland, Australia, 4812
        • Pfizer Investigational Site
      • Townsville, Queensland, Australia, 4814
        • Pfizer Investigational Site
      • Woolloongabba, Queensland, Australia, 4102
        • Pfizer Investigational Site
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Pfizer Investigational Site
      • Toorak Gardens, South Australia, Australia, 5065
        • Pfizer Investigational Site
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Pfizer Investigational Site
      • East Ringwood, Victoria, Australia, 3135
        • Pfizer Investigational Site
      • Wodonga, Victoria, Australia, 3690
        • Pfizer Investigational Site
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Pfizer Investigational Site
  • Belgium
      • Gent, Belgium, 9000
        • Pfizer Investigational Site
      • Liège, Belgium, 4000
        • Pfizer Investigational Site
  • Canada
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H2A 1A1
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H3G 1A4
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H3T 1E2
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H3T 1M5
        • Pfizer Investigational Site
      • Rimouski, Quebec, Canada, G5L 5T1
        • Pfizer Investigational Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Pfizer Investigational Site
  • China
      • Beijing, China, 100021
        • Pfizer Investigational Site
      • Beijing, China, 100071
        • Pfizer Investigational Site
      • Shanghai, China, 200032
        • Pfizer Investigational Site
    • Liaoning
      • Dalian, Xigang District, Liaoning, China, 116011
        • Pfizer Investigational Site
  • Cyprus
      • Nicosia, Cyprus, 2006
        • Pfizer Investigational Site
  • Czech Republic
      • Nova Ves Pod Plesi, Czech Republic, 26204
        • Pfizer Investigational Site
      • Ostrava-Poruba, Czech Republic, 708 52
        • Pfizer Investigational Site
      • Usti nad Labem, Czech Republic, 401 13
        • Pfizer Investigational Site
  • France
      • Angers cedex, France, 49033
        • Pfizer Investigational Site
      • Caen cedex, France, 14033
        • Pfizer Investigational Site
      • Dijon, France
        • Pfizer Investigational Site
      • Limoges, France, 87042
        • Pfizer Investigational Site
      • Nantes Cedex 2, France, 44202
        • Pfizer Investigational Site
      • Paris Cedex 13, France, 75651
        • Pfizer Investigational Site
      • St Herblain Cedex, France, 44805
        • Pfizer Investigational Site
      • Strasbourg, France, 67065 Cedex
        • Pfizer Investigational Site
      • Toulouse cedex 9, France, 31059
        • Pfizer Investigational Site
      • Vandoeuvre Les Nancy, France, 54511
        • Pfizer Investigational Site
  • Germany
      • Berlin, Germany, 10117
        • Pfizer Investigational Site
      • Bielefeld, Germany, 33611
        • Pfizer Investigational Site
      • Bonn, Germany, 53105
        • Pfizer Investigational Site
      • Essen, Germany, 45122
        • Pfizer Investigational Site
      • Frankfurt, Germany, 60590
        • Pfizer Investigational Site
      • Karlsruhe, Germany, 76137
        • Pfizer Investigational Site
      • Muenchen, Germany, 80336
        • Pfizer Investigational Site
  • Greece
      • Athens, Greece, 115 27
        • Pfizer Investigational Site
      • Rio, Patras, Greece, 26500
        • Pfizer Investigational Site
    • Attica
      • Athens, Attica, Greece, 11526
        • Pfizer Investigational Site
    • Crete
      • Heraklion, Crete, Greece, 71 500
        • Pfizer Investigational Site
    • Macedonia
      • Thessaloniki, Macedonia, Greece, 56 403
        • Pfizer Investigational Site
  • Hong Kong
      • Pokfulam, Hong Kong
        • Pfizer Investigational Site
  • Hungary
      • Budapest, Hungary, 1122
        • Pfizer Investigational Site
      • Budapest, Hungary, 1125
        • Pfizer Investigational Site
      • Budapest, Hungary, 1529
        • Pfizer Investigational Site
      • Debrecen, Hungary, 4032
        • Pfizer Investigational Site
  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560 034
        • Pfizer Investigational Site
    • Kerala
      • Kochi, Kerala, India, 682 026
        • Pfizer Investigational Site
    • Maharashtra
      • Pune, Maharashtra, India, 411 001
        • Pfizer Investigational Site
    • Punjab
      • Chandigarh, Punjab, India, 160 012
        • Pfizer Investigational Site
    • Rajasthan
      • Jaipur, Rajasthan, India, 302017
        • Pfizer Investigational Site
  • Israel
      • Zerifin, Israel, 70300
        • Pfizer Investigational Site
  • Italy
      • Lido di Camaiore (LU), Italy, 55043
        • Pfizer Investigational Site
      • Milano, Italy, 20133
        • Pfizer Investigational Site
      • Napoli, Italy, 81013
        • Pfizer Investigational Site
      • Pavia, Italy, 27100
        • Pfizer Investigational Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 110-744
        • Pfizer Investigational Site
  • Mexico
      • Puebla, Mexico, 72530
        • Pfizer Investigational Site
    • DF
      • Mexico, DF, Mexico, 14080
        • Pfizer Investigational Site
  • Netherlands
      • Amstelveen, Netherlands, 1186 AM
        • Pfizer Investigational Site
      • Den Haag, Netherlands, 2545 CH
        • Pfizer Investigational Site
    • GLD
      • Tiel, GLD, Netherlands, 4002 WP
        • Pfizer Investigational Site
    • GR
      • Groningen, GR, Netherlands, 9713 GZ
        • Pfizer Investigational Site
  • Poland
      • Otwock, Poland, 05-400
        • Pfizer Investigational Site
      • Wodzislaw Sl., Poland, 44-300
        • Pfizer Investigational Site
  • Portugal
      • Faro, Portugal, 8000-386
        • Pfizer Investigational Site
      • Porto, Portugal, 4099-001
        • Pfizer Investigational Site
      • Porto, Portugal, 4202
        • Pfizer Investigational Site
      • Vila Nova de Gaia, Portugal, 4400
        • Pfizer Investigational Site
  • South Africa
      • Cape Town, South Africa, 7500
        • Pfizer Investigational Site
      • Cape Town, South Africa, 7925
        • Pfizer Investigational Site
      • Johannesburg, South Africa, 2193
        • Pfizer Investigational Site
    • Gauteng
      • Parktown, Gauteng, South Africa
        • Pfizer Investigational Site
  • Spain
      • Madrid, Spain, 28007
        • Pfizer Investigational Site
      • Madrid, Spain, 28041
        • Pfizer Investigational Site
      • Santa Cruz de Tenerife, Spain, 38320
        • Pfizer Investigational Site
      • Valencia, Spain, 46014
        • Pfizer Investigational Site
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Pfizer Investigational Site
    • Madrid
      • Alcorcon, Madrid, Spain, 28922
        • Pfizer Investigational Site
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Pfizer Investigational Site
  • Sweden
      • Stockholm, Sweden, 118 83
        • Pfizer Investigational Site
      • Uppsala, Sweden, 751 85
        • Pfizer Investigational Site
  • Switzerland
      • Lausanne, Switzerland, CH-1011
        • Pfizer Investigational Site
  • Taiwan
      • Taipei, Taiwan, 112
        • Pfizer Investigational Site
  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Pfizer Investigational Site
      • Portsmouth, United Kingdom, PO3 6AD
        • Pfizer Investigational Site
      • Sheffield, United Kingdom, S10 2SJ
        • Pfizer Investigational Site
      • Surrey GU2 5XX, United Kingdom
        • Pfizer Investigational Site
      • Swansea, United Kingdom, SA2 8QA
        • Pfizer Investigational Site
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3LJ
        • Pfizer Investigational Site
    • Devon
      • Exeter, Devon, United Kingdom, EX2 5DW
        • Pfizer Investigational Site
  • United States
    • Alaska
      • Little Rock, Alaska, United States, 72205
        • Pfizer Investigational Site
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Pfizer Investigational Site
    • California
      • Chula Vista, California, United States, 91911
        • Pfizer Investigational Site
      • La Mesa, California, United States, 91942
        • Pfizer Investigational Site
      • Oceanside, California, United States, 92056
        • Pfizer Investigational Site
      • Palm Springs, California, United States, 92262-4885
        • Pfizer Investigational Site
      • San Diego, California, United States, 92123
        • Pfizer Investigational Site
      • San Francisco, California, United States, 94115
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Pfizer Investigational Site
      • Atlanta, Georgia, United States, 30342
        • Pfizer Investigational Site
      • Atlanta, Georgia, United States, 30309
        • Pfizer Investigational Site
      • Atlanta, Georgia, United States, 30322
        • Pfizer Investigational Site
      • Atlanta, Georgia, United States, 30306
        • Pfizer Investigational Site
      • Decatur, Georgia, United States, 30033
        • Pfizer Investigational Site
      • Fayetteville, Georgia, United States, 30214
        • Pfizer Investigational Site
      • Macon, Georgia, United States, 31217
        • Pfizer Investigational Site
      • Marietta, Georgia, United States, 30060
        • Pfizer Investigational Site
      • Tucker, Georgia, United States, 30084
        • Pfizer Investigational Site
    • Illinois
      • Rockford, Illinois, United States, 61104
        • Pfizer Investigational Site
    • Indiana
      • Jefferson, Indiana, United States, 47130
        • Pfizer Investigational Site
      • New Albany, Indiana, United States, 47150-6809
        • Pfizer Investigational Site
    • Iowa
      • Cedar Rapids, Iowa, United States, 52403
        • Pfizer Investigational Site
      • Dubuque, Iowa, United States, 52001
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Pfizer Investigational Site
      • Louisville, Kentucky, United States, 40202
        • Pfizer Investigational Site
      • Louisville, Kentucky, United States, 40217
        • Pfizer Investigational Site
      • Louisville, Kentucky, United States, 40241
        • Pfizer Investigational Site
      • Louisville, Kentucky, United States, 40505-4816
        • Pfizer Investigational Site
      • Shelbyville, Kentucky, United States, 40065
        • Pfizer Investigational Site
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • Pfizer Investigational Site
      • Gretna, Louisiana, United States, 70056
        • Pfizer Investigational Site
      • Lafayette, Louisiana, United States, 70503
        • Pfizer Investigational Site
      • Marrero, Louisiana, United States, 70006
        • Pfizer Investigational Site
      • Marrero, Louisiana, United States, 70072
        • Pfizer Investigational Site
      • Metairie, Louisiana, United States, 70006
        • Pfizer Investigational Site
      • New Orleans, Louisiana, United States, 70115
        • Pfizer Investigational Site
    • Maine
      • Biddeford, Maine, United States, 04005
        • Pfizer Investigational Site
      • Brunswick, Maine, United States, 04011
        • Pfizer Investigational Site
      • Scarborough, Maine, United States, 04074
        • Pfizer Investigational Site
    • Massachusetts
      • Worcester, Massachusetts, United States, 01608
        • Pfizer Investigational Site
    • Michigan
      • Allegan, Michigan, United States, 49010
        • Pfizer Investigational Site
      • Ann Arbor, Michigan, United States, 48109-0848
        • Pfizer Investigational Site
      • Ann Arbor, Michigan, United States, 48109
        • Pfizer Investigational Site
      • Kalamazoo, Michigan, United States, 49007
        • Pfizer Investigational Site
      • Kalamazoo, Michigan, United States, 49048
        • Pfizer Investigational Site
      • St. Joseph, Michigan, United States, 49085
        • Pfizer Investigational Site
    • Mississippi
      • Columbus, Mississippi, United States, 39705
        • Pfizer Investigational Site
      • Corinth, Mississippi, United States, 38834
        • Pfizer Investigational Site
      • Tupelo, Mississippi, United States, 38801
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Pfizer Investigational Site
      • Omaha, Nebraska, United States, 68124
        • Pfizer Investigational Site
      • Omaha, Nebraska, United States, 68130
        • Pfizer Investigational Site
      • Papillion, Nebraska, United States, 68046
        • Pfizer Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Pfizer Investigational Site
      • Las Vegas, Nevada, United States, 89106
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Pfizer Investigational Site
      • Ruidoso, New Mexico, United States, 88345
        • Pfizer Investigational Site
    • New York
      • Buffalo, New York, United States, 14263
        • Pfizer Investigational Site
      • Great Neck, New York, United States, 11023
        • Pfizer Investigational Site
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Pfizer Investigational Site
      • Brevard, North Carolina, United States, 28712
        • Pfizer Investigational Site
      • Lexington, North Carolina, United States, 27292
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Pfizer Investigational Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • Pfizer Investigational Site
      • Dover, Ohio, United States, 44622
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112-4491
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97227-1191
        • Pfizer Investigational Site
    • Pennsylvania
      • Langhorne, Pennsylvania, United States, 19047
        • Pfizer Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404-3324
        • Pfizer Investigational Site
      • Memphis, Tennessee, United States, 38120
        • Pfizer Investigational Site
    • Texas
      • Arlington, Texas, United States, 76012
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75230
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75235-7786
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75235
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75390-8590
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75390-9015
        • Pfizer Investigational Site
      • Richardson, Texas, United States, 75080
        • Pfizer Investigational Site
      • Trophy Club, Texas, United States, 76262
        • Pfizer Investigational Site
    • Utah
      • Bountiful, Utah, United States, 84010
        • Pfizer Investigational Site
      • Layton, Utah, United States, 84041
        • Pfizer Investigational Site
      • Murray, Utah, United States, 84107
        • Pfizer Investigational Site
      • Provo, Utah, United States, 84604
        • Pfizer Investigational Site
      • Salt Lake City, Utah, United States, 84106
        • Pfizer Investigational Site
      • WVC, Utah, United States, 84120
        • Pfizer Investigational Site
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Pfizer Investigational Site
    • Washington
      • Everett, Washington, United States, 98201
        • Pfizer Investigational Site
      • Kennewick, Washington, United States, 99336
        • Pfizer Investigational Site
      • Richland, Washington, United States, 99352
        • Pfizer Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-5666
        • 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 Non-Small-Cell Lung Cancer (NSCLC) stage IIIB with pleural effusion or stage IV
  • No prior systemic treatment for Non-Small-Cell Lung Cancer (NSCLC)with chemotherapy, immunotherapy, biologic response modifiers or other investigational drugs
  • Eastern Cooperative Oncology Performance Status (ECOG PS) 0 or 1

Exclusion Criteria:

  • Small cell or carcinoid lung cancer
  • Known Central Nervous System (CNS) metastasis
  • Pre-existing auto-immune or antibody mediated diseases

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
Experimental: A
Standard of care chemotherapy plus experiment intervention (PF-3512676)
Drug: PF-3512676 + Paclitaxel + Carboplatin
  • PF-3512676: 0.2 mg/kg subcutaneously Days 8 and 15 of each 21 day cycle x 6 cycles then weekly as maintenance until disease progression or unacceptable toxicity.
  • Paclitaxel: 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles.
  • Carboplatin: AUC 6 intravenously Day 1 of each 21 days cycle x 6 cycles.
Other Names:
  • Taxol; Paraplatin
Active Comparator: B
Standard of care chemotherapy
Drug: Paclitaxel + Carboplatin
  • Paclitaxel: 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles.
  • Carboplatin: AUC 6 intravenously Day 1 of each 21 days cycle x 6 cycles.
Other Names:
  • Taxol; Paraplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 656 Events
656 Events

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Objective Response
Time Frame: End of Treatment
End of Treatment
Time to Tumor Progression
Time Frame: Time of progressive disease
Time of progressive disease
Progression Free Survival
Time Frame: Time of primary endpoint
Time of primary endpoint
Duration of Response
Time Frame: Time of progressive disease
Time of progressive disease
Patient Reported Outcomes
Time Frame: End of Treatment
End of Treatment
Overall Safety Profile
Time Frame: 28 days post PF-3512676 dosing
28 days post PF-3512676 dosing

Collaborators and Investigators

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

Sponsor

Pfizer

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

November 1, 2005

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

November 15, 2005

First Submitted That Met QC Criteria

November 15, 2005

First Posted (Estimate)

November 17, 2005

Study Record Updates

Last Update Posted (Estimate)

March 30, 2015

Last Update Submitted That Met QC Criteria

March 10, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A8501001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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Conditions

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Locations

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