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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2008-05-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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B

Standard of care chemotherapy

Group Type ACTIVE_COMPARATOR

paclitaxel + carboplatin + bevacizumab

Intervention Type DRUG

paclitaxel 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles

A

Standard of care chemotherapy plus experimental intervention (PF-3512676)

Group Type EXPERIMENTAL

carboplatin + paclitaxel + bevacizumab + PF-3512676

Intervention Type DRUG

carboplatin AUC 6 intravenously on Day 1 of each 21 day cycle x 6 cycles

Interventions

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paclitaxel + carboplatin + bevacizumab

paclitaxel 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles

Intervention Type DRUG

carboplatin + paclitaxel + bevacizumab + PF-3512676

carboplatin AUC 6 intravenously on Day 1 of each 21 day cycle x 6 cycles

Intervention Type DRUG

Other Intervention Names

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Taxol; Paraplatin Paraplatin; Taxol; Avastin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No