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

Last updated on December 16, 2017

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

NCT00313768
Pfizer
Terminated
Randomized Ph 2 Trial Of Paclitaxel/Carboplatin /Bevacizumab + PF-3512676 And P/C/B Alone In Advanced Nonsquamous NSCLC

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Randomized Ph 2 Trial Of Paclitaxel/Carboplatin /Bevacizumab + PF-3512676 And P/C/B Alone In Advanced Nonsquamous NSCLC
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
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Carcinoma, Non-Small-Cell Lung
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
23
May 2008
May 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00313768
A8501003
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

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