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A Study Of AG-013736 (Axitinib) Or Bevacizumab (Avastin) In Combination With Paclitaxel And Carboplatin In Patients With Advanced Lung Cancer.
This study is currently recruiting participants.
Verified by Pfizer, May 2009
First Received: January 3, 2008   Last Updated: May 8, 2009   History of Changes
Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00600821
  Purpose

To determine if the addition of AG-013736 to chemotherapy is beneficial in patients with advanced lung cancer who have not been previously treated.


Condition Intervention Phase
Non-Small-Cell Lung Carcinoma
Adenocarcinoma
 Drug: Bevacizumab + Carboplatin + Paclitaxel
Drug: AG-013736 (axitinib) + Carboplatin + Paclitaxel
 Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Paclitaxel Carboplatin Bevacizumab Axitinib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title: Randomized Phase 2 Trial Of AG013736 Or Bevacizumab In Combination With Paclitaxel And Carboplatin As First Line Treatment For Patients With Advanced Non Small Cell Lung Cancer

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 2.5 yrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Population PK [ Time Frame: 2.5 yrs ] [ Designated as safety issue: Yes ]
  • Molecular profiling and biomarkers [ Time Frame: 2.5 yrs ] [ Designated as safety issue: Yes ]
  • Overall Survival [ Time Frame: 3 yrs ] [ Designated as safety issue: No ]
  • Overall confirmed objective response rate [ Time Frame: 2.5 yrs ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: 2.5 yrs ] [ Designated as safety issue: No ]
  • Overall safety profile [ Time Frame: 2.5 yrs ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 108
Study Start Date: April 2008
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
B: Active Comparator
Bevacizumab will be given with carboplatin and paclitaxel, every 3 weeks.
Drug: Bevacizumab + Carboplatin + Paclitaxel
Bevacizumab is a VEGF inhibitor that binds the ligand. Bevacizumab will be given with carboplatin and paclitaxel, every 3 weeks.
A: Experimental
AG-013736 will be given with carboplatin and paclitaxel, every 3 weeks.
Drug: AG-013736 (axitinib) + Carboplatin + Paclitaxel
AG-013736 is a VEGF inhibitor that binds the receptor for VEGF 1, 2, and 3. Carboplatin will be given in combination with paclitaxel. In Arm A, patients also receive AG-013736 and in Arm B, patients receive bevacizumab. Paclitaxel will be given in combination with carboplatin. In Arm A, patients also receive AG-013736 and in Arm B, patients receive bevacizumab.

  Eligibility

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

Inclusion Criteria:

  • Advanced non squamous cell, lung cancer
  • No prior treatment for lung cancer except prior adjuvant therapy if last dose was >12 months prior to enrollment

Exclusion Criteria:

  • Prior therapy for advanced lung cancer
  • The need for blood-thinners
  • Coughing up blood
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00600821

Contacts
Contact: Pfizer Oncology Clinical Trial Information Service 1-877-369-9753 PfizerCancerTrials@emergingmed.com
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Hide Study Locations
Locations
United States, California
Pfizer Investigational Site Not yet recruiting
Encinitas, California, United States, 92024
Pfizer Investigational Site Not yet recruiting
La Jolla, California, United States, 92037
Pfizer Investigational Site Not yet recruiting
San Diego, California, United States, 92128
United States, Illinois
Pfizer Investigational Site Not yet recruiting
Maryville, Illinois, United States, 62062
United States, Louisiana
Pfizer Investigational Site Recruiting
Baton Rouge, Louisiana, United States, 70809
United States, Massachusetts
Pfizer Investigational Site Recruiting
Pittsfield, Massachusetts, United States, 01201
United States, Mississippi
Pfizer Investigational Site Recruiting
Southaven, Mississippi, United States, 38671
Pfizer Investigational Site Recruiting
Corinth, Mississippi, United States, 38834
Pfizer Investigational Site Recruiting
Tupelo, Mississippi, United States, 38801
Pfizer Investigational Site Active, not recruiting
New Albany, Mississippi, United States, 38652
Pfizer Investigational Site Recruiting
Oxford, Mississippi, United States, 38655
Pfizer Investigational Site Recruiting
Columbus, Mississippi, United States, 39705
United States, Nebraska
Pfizer Investigational Site Recruiting
Lincoln, Nebraska, United States, 68510
United States, Ohio
Pfizer Investigational Site Recruiting
Cleveland, Ohio, United States, 44109
United States, Tennessee
Pfizer Investigational Site Recruiting
Crossville, Tennessee, United States, 38555
Pfizer Investigational Site Active, not recruiting
Germantown, Tennessee, United States, 38138
Pfizer Investigational Site Recruiting
Collierville, Tennessee, United States, 38017
Pfizer Investigational Site Recruiting
Bartlett, Tennessee, United States, 38133
Pfizer Investigational Site Recruiting
Chattanooga, Tennessee, United States, 37403
Pfizer Investigational Site Recruiting
Memphis, Tennessee, United States, 38119
Pfizer Investigational Site Recruiting
Memphis, Tennessee, United States, 38120
United States, Texas
Pfizer Investigational Site Recruiting
Dallas, Texas, United States, 75230
Pfizer Investigational Site Recruiting
Dallas, Texas, United States, 75246
Pfizer Investigational Site Recruiting
San Antonio, Texas, United States, 78229
Pfizer Investigational Site Recruiting
San Antonio, Texas, United States, 78284
Pfizer Investigational Site Recruiting
Dallas, Texas, United States, 75235
Pfizer Investigational Site Recruiting
Dallas, Texas, United States, 75390-8590
Pfizer Investigational Site Recruiting
Lubbock, Texas, United States, 79410
United States, Washington
Pfizer Investigational Site Recruiting
Wenatchee, Washington, United States, 98801
Czech Republic
Pfizer Investigational Site Active, not recruiting
Usti nad Labem, Czech Republic, 401 13
Pfizer Investigational Site Active, not recruiting
Praha 8, Czech Republic, 180 81
Pfizer Investigational Site Active, not recruiting
Tabor, Czech Republic, 390 03
France
Pfizer Investigational Site Active, not recruiting
Pierre-Bénite, France, 69310
Pfizer Investigational Site Not yet recruiting
Vesoul Cedex, France, 70014
Pfizer Investigational Site Recruiting
Paris Cedex 14, France, 75679
Pfizer Investigational Site Recruiting
Caen Cedex 05, France, 14076
Poland
Pfizer Investigational Site Recruiting
Bydgoszcz, Poland, 85-796
Pfizer Investigational Site Recruiting
Torun, Poland, 87 - 100
Pfizer Investigational Site Recruiting
Gdynia, Poland, 81-519
Pfizer Investigational Site Active, not recruiting
Warszawa, Poland, 02-097
Pfizer Investigational Site Recruiting
Gdansk, Poland, 80-462
Spain
Pfizer Investigational Site Recruiting
ALICANTE, Spain, 03010
Pfizer Investigational Site Recruiting
VALENCIA, Spain, 46014
Spain, BARCELONA
Pfizer Investigational Site Recruiting
SABADELL, BARCELONA, Spain, 08208
Pfizer Investigational Site Recruiting
MATARO, BARCELONA, Spain, 08304
United Kingdom
Pfizer Investigational Site Active, not recruiting
London, United Kingdom, NW1 2PG
Pfizer Investigational Site Active, not recruiting
London, United Kingdom, SW3 6JJ
Pfizer Investigational Site Active, not recruiting
Surrey, United Kingdom, SM2 5PT
United Kingdom, Hampshire
Pfizer Investigational Site Active, not recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
United Kingdom, Scotland
Pfizer Investigational Site Recruiting
Dundee, Scotland, United Kingdom, DD1 9SY
United Kingdom, Yorkshire
Pfizer Investigational Site Active, not recruiting
Leeds, Yorkshire, United Kingdom, LS9 7TF
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: Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers: A4061030
Study First Received: January 3, 2008
Last Updated: May 8, 2009
ClinicalTrials.gov Identifier: NCT00600821     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Thoracic Neoplasms
Antimitotic Agents
Bevacizumab
Carboplatin
Angiogenesis Inhibitors
Carcinoma
Respiratory Tract Diseases
Lung Neoplasms
 Paclitaxel
Lung Diseases
Tubulin Modulators
Non-small Cell Lung Cancer
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Bevacizumab
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Growth Substances
 Mitosis Modulators
Carboplatin
Antimitotic Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Paclitaxel
Lung Diseases
Tubulin Modulators
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 13, 2009



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