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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

Tracking Information
First Submitted Date  ICMJE April 10, 2006
First Posted Date  ICMJE April 12, 2006
Last Update Posted Date September 28, 2009
Study Start Date  ICMJE December 2005
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
Progression-free survival [ Time Frame: 110 Events ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 10, 2006)
Progression-free survival
Change History Complete list of historical versions of study NCT00313768 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
  • Time to Tumor Progression [ Time Frame: End of treatment ]
  • Overall Objective Response Rate [ Time Frame: Time of progressive disease ]
  • Duration of Response [ Time Frame: Time of progression ]
  • Overall Survival [ Time Frame: Time of death ]
  • Overall safety profile [ Time Frame: 28 days post treatment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2006)
Time to Tumor Progression Overall Objective Response Rate Duration of Response Overall Survival Biomarkers of Immune Activation
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Ph 2 Trial Of Paclitaxel/Carboplatin /Bevacizumab + PF-3512676 And P/C/B Alone In Advanced Nonsquamous NSCLC
Official Title  ICMJE 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
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
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • Drug: paclitaxel + carboplatin + bevacizumab
    paclitaxel 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles
    Other Name: Taxol; Paraplatin
  • 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
Study Arms  ICMJE
  • Active Comparator: B
    Standard of care chemotherapy
    Intervention: Drug: paclitaxel + carboplatin + bevacizumab
  • Experimental: A
    Standard of care chemotherapy plus experimental intervention (PF-3512676)
    Intervention: Drug: carboplatin + paclitaxel + bevacizumab + PF-3512676
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 8, 2008)
23
Original Enrollment  ICMJE
 (submitted: April 10, 2006)
140
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00313768
Other Study ID Numbers  ICMJE A8501003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP