Clinical trial NCT00600821: A Study Of AG-013736 (Axitinib) Or Bevacizumab (Avastin) In Combination With Paclitaxel And Carboplatin In Patients With Advanced Lung Cancer.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small-Cell Lung Carcinoma
Adenocarcinoma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-01-25
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Baseline, every 6 weeks until disease progression or initiation of subsequent anticancer therapy up to 2.75 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Baseline, every 6 weeks until death or bimonthly after final study visit (up to 2.75 years)
measure: Percentage of Participants With Objective Response (OR)
timeFrame: Baseline, every 6 weeks until disease progression or initiation of subsequent anticancer therapy up to 2.75 years
measure: Duration of Response (DR)
timeFrame: Baseline, every 6 weeks until disease progression or initiation of subsequent anticancer therapy up to 2.75 years
measure: Population Pharmacokinetic (PK) Analysis for Axitinib (AG-013736)
timeFrame: Pre-dose, 1 to 2 hours post-dose on Cycle 2 of Day 1 and Cycle 3 of Day 1
measure: European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score
timeFrame: Day (D) 1 of every cycle (C) then every 3 weeks until final study visit (up to 2.75 years)
measure: European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score
timeFrame: Day 1 of every cycle then every 3 weeks until final study visit (up to 2.75 years)
measure: Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile in Whole Blood
timeFrame: Baseline, C1 D1, C1 D15, C2 D1, C3 D1, C4 D1 and C5 D1
measure: Circulating Endothelial Cells (CEC) in Blood: Total CEC
timeFrame: Baseline (C1 D1), C1 D15, C2 D1, C3 D1, C4 D1, C5 D1, C7 D1, C9 D1 and C11 D1
measure: Circulating Endothelial Cells (CEC) in Blood
timeFrame: Baseline (C1 D1), C1 D15, C2 D1, C3 D1, C4 D1, C5 D1, C7 D1, C9 D1 and C11 D1
measure: Plasma Concentration of Soluble Proteins
timeFrame: Baseline, C1D1, C1D15, C2D1, C3D1, C4D1, C5D1, C7D1, C9D1 and C11D1
Other outcomes:
measure: Plasma Concentration Change in the Uridine Diphosphate Glucuronosyltransferase 1A1 (UGT1A1) Genotype
timeFrame: Baseline (Day 1 of Cycle 1)
Locations:
city: Baton Rouge
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Pittsfield
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Corinth
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: New Albany
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Oxford
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Southaven
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Tupelo
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Lincoln
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Bartlett
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Germantown
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Lubbock
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Wenatchee
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Praha 8
country: Czech Republic
facility: Pfizer Investigational Site
city: Tabor
country: Czech Republic
facility: Pfizer Investigational Site
city: Usti nad Labem
country: Czech Republic
facility: Pfizer Investigational Site
city: Caen Cedex 05
country: France
facility: Pfizer Investigational Site
city: Paris Cedex 14
country: France
facility: Pfizer Investigational Site
city: Pierre-Bénite
country: France
facility: Pfizer Investigational Site
city: Bydgoszcz
country: Poland
facility: Pfizer Investigational Site
city: Gdansk
country: Poland
facility: Pfizer Investigational Site
city: Gdynia
country: Poland
facility: Pfizer Investigational Site
city: Torun
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Mataro
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Sabadell
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Alicante
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Southampton
country: United Kingdom
facility: Pfizer Investigational Site
state: Hampshire
city: Dundee
country: United Kingdom
facility: Pfizer Investigational Site
state: Scotland
city: Leeds
country: United Kingdom
facility: Pfizer Investigational Site
state: Yorkshire
city: Dundee
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: Surrey
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Twelves C, Chmielowska E, Havel L, Popat S, Swieboda-Sadlej A, Sawrycki P, Bycott P, Ingrosso A, Kim S, Williams JA, Chen C, Olszanski AJ, de Besi P, Schiller JH. Randomised phase II study of axitinib or bevacizumab combined with paclitaxel/carboplatin as first-line therapy for patients with advanced non-small-cell lung cancer. Ann Oncol. 2014 Jan;25(1):132-8. doi: 10.1093/annonc/mdt489.