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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00313768

Purpose

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

Condition	Intervention	Phase
Carcinoma, Non-Small-Cell Lung	Drug: paclitaxel + carboplatin + bevacizumab Drug: carboplatin + paclitaxel + bevacizumab + PF-3512676	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Paclitaxel Carboplatin Bevacizumab

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	23
Study Start Date:	December 2005
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: B Standard of care chemotherapy	Drug: paclitaxel + carboplatin + bevacizumab paclitaxel 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles Other Name: Taxol; Paraplatin
Experimental: A Standard of care chemotherapy plus experimental intervention (PF-3512676)	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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00313768

Locations

United States, Alabama
Pfizer Investigational Site
Bessemer, Alabama, United States, 35022
Pfizer Investigational Site
Birmingham, Alabama, United States, 32511
Pfizer Investigational Site
Birmingham, Alabama, United States, 35205
Pfizer Investigational Site
Birmingham, Alabama, United States, 35209
Pfizer Investigational Site
Birmingham, Alabama, United States, 35213
Pfizer Investigational Site
Birmingham, Alabama, United States, 35235
Pfizer Investigational Site
Mobile, Alabama, United States, 36607
United States, California
Pfizer Investigational Site
Fountain Valley, California, United States, 92708
Pfizer Investigational Site
Los Angeles, California, United States, 90033
United States, Florida
Pfizer Investigational Site
Cocoa Beach, Florida, United States, 32931
Pfizer Investigational Site
Merritt Island, Florida, United States, 32952
Pfizer Investigational Site
Rockledge, Florida, United States, 32955
Pfizer Investigational Site
Titusville, Florida, United States, 32796
United States, Georgia
Pfizer Investigational Site
Valdosta, Georgia, United States, 31602
United States, Illinois
Pfizer Investigational Site
Joliet, Illinois, United States, 60432
Pfizer Investigational Site
Joliet, Illinois, United States, 60435
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21231
United States, North Carolina
Pfizer Investigational Site
Clinton, North Carolina, United States, 28382
Pfizer Investigational Site
Goldsboro, North Carolina, United States, 27534
Pfizer Investigational Site
Pollocksville, North Carolina, United States, 28573
Pfizer Investigational Site
Wilson, North Carolina, United States, 27893
United States, Tennessee
Pfizer Investigational Site
Knoxville, Tennessee, United States, 37920
Pfizer Investigational Site
Knoxville, Tennessee, United States, 37934
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78705
Pfizer Investigational Site
Austin, Texas, United States, 78745
Pfizer Investigational Site
Austin, Texas, United States, 78758
Pfizer Investigational Site
Austin, Texas, United States, 78759
Pfizer Investigational Site
Georgetown, Texas, United States, 78626
Pfizer Investigational Site
San Marcos, Texas, United States, 78666

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier:	NCT00313768 History of Changes
Other Study ID Numbers:	A8501003
Study First Received:	April 10, 2006
Last Updated:	September 24, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

advanced carcinoma, non-small cell lung, Phase II, paclitaxel, Taxol, carboplatin, Paraplatin, bevacizumab, Avastin, PF-3512676, immunotherapy, immunomodulator

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Bevacizumab
Carboplatin

Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on February 12, 2012