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Trial of Paclitaxel/Carboplat...

Trial of Paclitaxel/Carboplatin + PF-3512676 vs Paclitaxel/Carboplatin Alone in Patients With Advanced Non-Small Cell Lung Cancer

Last Updated: 2015-03-30

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

PHASE3

Total Enrollment

828 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2008-07-31

Brief Summary

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To assess the efficacy and safety of PF-3512676 administered in combination with paclitaxel/carboplatin chemotherapy as first-line treatment in patients with locally advanced or metastatic Non-Small-Cell Lung Cancer (NSCLC) and to compare it to the efficacy and safety of paclitaxel

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Detailed Description

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PF-3512676 dosing was stopped 20 June 2007 in response to DSMC recommendation to close the trial, citing lack of efficacy concerns as the primary reason with a safety issue (sepsis) also contributing to the decision. Subjects were allowed to complete standard of care treatment/survival follow-up. Data collection was completed on 17 July 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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A

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

Group Type EXPERIMENTAL

PF-3512676 + Paclitaxel + Carboplatin

Intervention Type DRUG

* PF-3512676: 0.2 mg/kg subcutaneously Days 8 and 15 of each 21 day cycle x 6 cycles then weekly as maintenance until disease progression or unacceptable toxicity.
* Paclitaxel: 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles.
* Carboplatin: AUC 6 intravenously Day 1 of each 21 days cycle x 6 cycles.

B

Standard of care chemotherapy

Group Type ACTIVE_COMPARATOR

Paclitaxel + Carboplatin

Intervention Type DRUG

* Paclitaxel: 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles.
* Carboplatin: AUC 6 intravenously Day 1 of each 21 days cycle x 6 cycles.

Interventions

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PF-3512676 + Paclitaxel + Carboplatin

Intervention Type DRUG

Paclitaxel + Carboplatin

* Paclitaxel: 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles.
* Carboplatin: AUC 6 intravenously Day 1 of each 21 days cycle x 6 cycles.

Intervention Type DRUG

Other Intervention Names

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Taxol; Paraplatin Taxol; Paraplatin

Eligibility Criteria

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Inclusion Criteria

* Advanced Non-Small-Cell Lung Cancer (NSCLC) stage IIIB with pleural effusion or stage IV
* No prior systemic treatment for Non-Small-Cell Lung Cancer (NSCLC)with chemotherapy, immunotherapy, biologic response modifiers or other investigational drugs
* Eastern Cooperative Oncology Performance Status (ECOG PS) 0 or 1

Exclusion Criteria

* Small cell or carcinoid lung cancer
* Known Central Nervous System (CNS) metastasis
* Pre-existing auto-immune or antibody mediated diseases

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Pfizer Inc

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Little Rock, Alaska, United States

Site Status

Pfizer Investigational Site

Hot Springs, Arkansas, United States

Site Status

Pfizer Investigational Site

Chula Vista, California, United States

Site Status

Pfizer Investigational Site

La Mesa, California, United States

Site Status

Pfizer Investigational Site

Oceanside, California, United States

Site Status

Pfizer Investigational Site

Palm Springs, California, United States

Site Status

Pfizer Investigational Site

San Diego, California, United States

Site Status