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

Phase 2

Terminated

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: paclitaxel + carboplatin + bevacizumab; Drug: carboplatin + paclitaxel + bevacizumab + PF-3512676

• Registration Number: NCT00313768
• Lead Sponsor: 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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2006-04-10
• Study First Submitted QC: 2006-04-10
• Study First Posted: 2006-04-12
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2009-09
• Disposition First Submitted: 2009-09-24
• Disposition First Submitted QC: 2009-09-24
• Last Update Submitted: 2009-09-24
• Disposition First Posted: 2009-09-28
• Last Update Posted: 2009-09-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	paclitaxel + carboplatin + bevacizumab	Standard of care chemotherapy
A	carboplatin + paclitaxel + bevacizumab + PF-3512676	Standard of care chemotherapy plus experimental intervention (PF-3512676)

Primary Outcome Measures

Name	Time	Method
Progression-free survival	110 Events

Secondary Outcome Measures

Name	Time	Method
Time to Tumor Progression	End of treatment
Overall Objective Response Rate	Time of progressive disease
Duration of Response	Time of progression
Overall Survival	Time of death
Overall safety profile	28 days post treatment

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 San Marcos, Texas, United States