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

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NCT00313768

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Study Location
Pfizer Investigational Site
Bessemer, Alabama, 35022, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Small-Cell Lung Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
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 CenterPfizer
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