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

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ClinicalTrials.gov Identifier: NCT00313768
Recruitment Status : Terminated (See Termination Reason in Detailed Description.)
First Posted : April 12, 2006
Last Update Posted : September 28, 2009
Sponsor:
Information provided by:
Pfizer

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: paclitaxel + carboplatin + bevacizumab Drug: carboplatin + paclitaxel + bevacizumab + PF-3512676 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2005
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Paraplatin; Taxol; Avastin




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 110 Events ]

Secondary Outcome Measures :
  1. Time to Tumor Progression [ Time Frame: End of treatment ]
  2. Overall Objective Response Rate [ Time Frame: Time of progressive disease ]
  3. Duration of Response [ Time Frame: Time of progression ]
  4. Overall Survival [ Time Frame: Time of death ]
  5. Overall safety profile [ Time Frame: 28 days post treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00313768


Locations
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United States, Alabama
Pfizer Investigational Site
Bessemer, Alabama, United States, 35022
Pfizer Investigational Site
Birmingham, Alabama, United States, 32511
Pfizer Investigational Site
Birmingham, Alabama, United States, 35205
Pfizer Investigational Site
Birmingham, Alabama, United States, 35209
Pfizer Investigational Site
Birmingham, Alabama, United States, 35213
Pfizer Investigational Site
Birmingham, Alabama, United States, 35235
Pfizer Investigational Site
Mobile, Alabama, United States, 36607
United States, California
Pfizer Investigational Site
Fountain Valley, California, United States, 92708
Pfizer Investigational Site
Los Angeles, California, United States, 90033
United States, Florida
Pfizer Investigational Site
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
United States, Georgia
Pfizer Investigational Site
Valdosta, Georgia, United States, 31602
United States, Illinois
Pfizer Investigational Site
Joliet, Illinois, United States, 60432
Pfizer Investigational Site
Joliet, Illinois, United States, 60435
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21231
United States, North Carolina
Pfizer Investigational Site
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
United States, Tennessee
Pfizer Investigational Site
Knoxville, Tennessee, United States, 37920
Pfizer Investigational Site
Knoxville, Tennessee, United States, 37934
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78705
Pfizer Investigational Site
Austin, Texas, United States, 78745
Pfizer Investigational Site
Austin, Texas, United States, 78758
Pfizer Investigational Site
Austin, Texas, United States, 78759
Pfizer Investigational Site
Georgetown, Texas, United States, 78626
Pfizer Investigational Site
San Marcos, Texas, United States, 78666
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00313768     History of Changes
Other Study ID Numbers: A8501003
First Posted: April 12, 2006    Key Record Dates
Last Update Posted: September 28, 2009
Last Verified: September 2009
Keywords provided by Pfizer:
advanced carcinoma, non-small cell lung, Phase II, paclitaxel, Taxol, carboplatin, Paraplatin, bevacizumab, Avastin, PF-3512676, immunotherapy, immunomodulator
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Bevacizumab
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors