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

Tracking Information

First Received Date ^ICMJE

April 10, 2006

Last Updated Date

September 24, 2009

Start Date ^ICMJE

December 2005

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Progression-free survival [ Time Frame: 110 Events ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Progression-free survival

Change History

Complete list of historical versions of study NCT00313768 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Time to Tumor Progression [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
Overall Objective Response Rate [ Time Frame: Time of progressive disease ] [ Designated as safety issue: No ]
Duration of Response [ Time Frame: Time of progression ] [ Designated as safety issue: No ]
Overall Survival [ Time Frame: Time of death ] [ Designated as safety issue: No ]
Overall safety profile [ Time Frame: 28 days post treatment ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Time to Tumor Progression Overall Objective Response Rate Duration of Response Overall Survival Biomarkers of Immune Activation

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Carcinoma, Non-Small-Cell Lung

Intervention ^ICMJE

Drug: paclitaxel + carboplatin + bevacizumab
Drug: carboplatin + paclitaxel + bevacizumab + PF-3512676

Study Arms / Comparison Groups

Active Comparator: Standard of care chemotherapy
Experimental: Standard of care chemotherapy plus experimental intervention (PF-3512676)

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

May 2008

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00313768

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer Inc

Study ID Numbers ^ICMJE

A8501003

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

September 2009

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