A Study Of AG-013736 (Axitinib) Or Bevacizumab (Avastin) In Combination With Paclitaxel And Carboplatin In Patients With Advanced Lung Cancer. - Full Text View

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.

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

Show 51 Study Locations

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 3, 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 06, 2009