Clinical trial NCT00471146: Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine For Advanced Pancreatic Cancer.
Official title: A Randomized, Double-Blind Phase 3 Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine Plus Placebo For The First-Line Treatment Of Patients With Locally Advanced, Unresectable Or Metastatic Pancreatic Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carcinoma, Pancreatic Ductal
Keywords: Randomized Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine Plus Placebo For Advanced Pancreatic Cancer.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-05-09
Enrollment: 630
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: The purpose of this study is to determine whether investigational study drug, AG-013736, and gemcitabine are effective in the first-line treatment of advanced pancreatic cancer.

Detailed description: This study was prematurely discontinued for futility on 23 January 2009, based on a planned interim analysis by an independent Data Safety Monitoring Board (DSMB) that found no evidence of improvement in the primary endpoint (survival) in patients treated with axitinib and gemcitabine compared to gemcitabine alone. Enrollment on this study has been discontinued.

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed, metastatic or locally-, advanced pancreatic adenocarcinoma not amenable to curative resection.
* Adequate renal, hepatic and bone marrow function.
* Performance status 0 or 1.

Exclusion Criteria:

* Prior treatment with any systemic chemotherapy for metastatic disease.
* Prior treatment with gemcitabine, AG-013736, or other vascular endothelial growth factor inhibitors.
* Current or recent bleeding, thromboembolic event and or use of a thrombolytic agent.
* Inability to take oral medication.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Baseline until death or at least 1 year after the randomization of last participant
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Baseline until disease progression or at least 1 year after the randomization of last participant
measure: Percentage of Participants With Objective Response (OR)
timeFrame: Baseline, every 8 weeks until tumor progression or death
measure: Duration of Response (DR)
timeFrame: Baseline until death or at least 1 year after the randomization of last participant
measure: Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score
timeFrame: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal
measure: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score
timeFrame: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal
measure: Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score
timeFrame: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal
measure: Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile
timeFrame: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal
measure: Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score
timeFrame: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal
measure: Population Pharmacokinetic (PK) Analysis for Axitinib (AG-013736)
timeFrame: Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 23 months
Other outcomes:
Locations:
city: Antioch
country: United States
facility: Pfizer Investigational Site
state: California
city: Corona
country: United States
facility: Pfizer Investigational Site
state: California
city: Glendora
country: United States
facility: Pfizer Investigational Site
state: California
city: La Jolla
country: United States
facility: Pfizer Investigational Site
state: California
city: La Jolla
country: United States
facility: Pfizer Investigational Site
state: California
city: LaVerne
country: United States
facility: Pfizer Investigational Site
state: California
city: Pamona
country: United States
facility: Pfizer Investigational Site
state: California
city: Pasadena
country: United States
facility: Pfizer Investigational Site
state: California
city: Pleasent Hill
country: United States
facility: Pfizer Investigational Site
state: California
city: Pomona
country: United States
facility: Pfizer Investigational Site
state: California
city: Rancho Cucamonga
country: United States
facility: Pfizer Investigational Site
state: California
city: Rancho Mirage
country: United States
facility: Pfizer Investigational Site
state: California
city: Redlands
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Leandro
country: United States
facility: Pfizer Investigational Site
state: California
city: West Covina
country: United States
facility: Pfizer Investigational Site
state: California
city: Hollywood
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Stuart
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Augusta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Augusta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Coeur D'Alene
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Alton
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Beech Grove
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Jeffersonville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Shelbyville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Baton Rouge
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Baton Rouge
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Annapolis
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Burlington
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Peabody
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Kalamazoo
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Corinth
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: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Billings
country: United States
facility: Pfizer Investigational Site
state: Montana
city: Lincoln
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Mineola
country: United States
facility: Pfizer Investigational Site
state: New York
city: Syracuse
country: United States
facility: Pfizer Investigational Site
state: New York
city: Canton
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Sylvania
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Knoxville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Knoxville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Knoxville
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: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Austin
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: Round Rock
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Lynchburg
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Everett
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Federal Way
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Kennewick
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Lakewood
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Puyallup
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Tacoma
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Bahia Blanca
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: La Plata
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Santa Fe
country: Argentina
facility: Pfizer Investigational Site
city: St. Leonards
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Wollongong
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Clayton
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: East Bentleigh
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Salzburg
country: Austria
facility: Pfizer Investigational Site
city: Wels
country: Austria
facility: Pfizer Investigational Site
city: Wien
country: Austria
facility: Pfizer Investigational Site
city: Wien
country: Austria
facility: Pfizer Investigational Site
city: Wien
country: Austria
facility: Pfizer Investigational Site
city: Brussel
country: Belgium
facility: Pfizer Investigational Site
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Gent
country: Belgium
facility: Pfizer Investigational Site
city: Leuven
country: Belgium
facility: Pfizer Investigational Site
city: Wilrijk
country: Belgium
facility: Pfizer Investigational Site
city: Edmonton
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Kelowna
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Victoria
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Moncton
country: Canada
facility: Pfizer Investigational Site
state: New Brunswick
city: Kingston
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Kingston
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Oshawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Clichy cedex
country: France
facility: Pfizer Investigational Site
city: La Chaussee Saint Victor
country: France
facility: Pfizer Investigational Site
city: Marseille
country: France
facility: Pfizer Investigational Site
city: Montpellier Cedex 02
country: France
facility: Pfizer Investigational Site
city: PARIS Cedex 13
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Pessac Cedex
country: France
facility: Pfizer Investigational Site
city: Rouen
country: France
facility: Pfizer Investigational Site
city: St Herblain Cedex
country: France
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Dresden
country: Germany
facility: Pfizer Investigational Site
city: Essen
country: Germany
facility: Pfizer Investigational Site
city: Greifswald
country: Germany
facility: Pfizer Investigational Site
city: Magdeburg
country: Germany
facility: Pfizer Investigational Site
city: Mannheim
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Oldenburg
country: Germany
facility: Pfizer Investigational Site
city: Ulm
country: Germany
facility: Pfizer Investigational Site
city: Shatin
country: Hong Kong
facility: Pfizer Investigational Site
state: NT
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Kaposvar
country: Hungary
facility: Pfizer Investigational Site
city: Szentes
country: Hungary
facility: Pfizer Investigational Site
city: Zalaegerszeg
country: Hungary
facility: Pfizer Investigational Site
city: Ahmedabad
country: India
facility: Pfizer Investigational Site
state: Gujarat
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Cochin
country: India
facility: Pfizer Investigational Site
state: Kerala
city: Andhra
country: India
facility: Pfizer Investigational Site
state: Pradesh
city: Chennai
country: India
facility: Pfizer Investigational Site
state: Tamil Nadu
city: Dublin 24
country: Ireland
facility: Pfizer Investigational Site
city: Dublin
country: Ireland
facility: Pfizer Investigational Site
city: Bologna
country: Italy
facility: Pfizer Investigational Site
city: Catania
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Padova
country: Italy
facility: Pfizer Investigational Site
city: Verona
country: Italy
facility: Pfizer Investigational Site
city: Nagoya
country: Japan
facility: Pfizer Investigational Site
state: Aichi
city: Chiba-shi
country: Japan
facility: Pfizer Investigational Site
state: Chiba-ken
city: Chiba city
country: Japan
facility: Pfizer Investigational Site
state: Chiba
city: Kashiwa-shi
country: Japan
facility: Pfizer Investigational Site
state: Chiba
city: Fukuoka-shi
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka-ken
city: Yokohama-shi
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Osaka-shi
country: Japan
facility: Pfizer Investigational Site
state: Osaka-fu
city: Suntougun
country: Japan
facility: Pfizer Investigational Site
state: Shizuoka
city: Chuo-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Amsterdam
country: Netherlands
facility: Pfizer Investigational Site
state: Noord Holland
city: Amsterdam
country: Netherlands
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Omsk
country: Russian Federation
facility: Pfizer Investigational Site
city: Sochi
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
city: Cape Town
country: South Africa
facility: Pfizer Investigational Site
city: Observatory
country: South Africa
facility: Pfizer Investigational Site
city: Parktown
country: South Africa
facility: Pfizer Investigational Site
city: Port Elizabeth
country: South Africa
facility: Pfizer Investigational Site
city: Pretoria
country: South Africa
facility: Pfizer Investigational Site
city: Sandton
country: South Africa
facility: Pfizer Investigational Site
city: Palma de Mallorca
country: Spain
facility: Pfizer Investigational Site
state: Islas Baleares
city: Mostoles
country: Spain
facility: Pfizer Investigational Site
state: Madrid
city: Pamplona
country: Spain
facility: Pfizer Investigational Site
state: Navarra
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Las Palmas de Gran Canaria
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Malaga
country: Spain
facility: Pfizer Investigational Site
city: Santa Cruz de Tenerife
country: Spain
facility: Pfizer Investigational Site
city: Toledo
country: Spain
facility: Pfizer Investigational Site
city: Lund
country: Sweden
facility: Pfizer Investigational Site
city: Uppsala
country: Sweden
facility: Pfizer Investigational Site
city: Winterthur
country: Switzerland
facility: Pfizer Investigational Site
city: Kuei-Shan Jsoamg
country: Taiwan
facility: Pfizer Investigational Site
state: Taoyuan County
city: Taichung
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Whitchurch
country: United Kingdom
facility: Pfizer Investigational Site
state: Cardiff
city: Maidstone
country: United Kingdom
facility: Pfizer Investigational Site
state: Kent
city: Leicester
country: United Kingdom
facility: Pfizer Investigational Site
state: Leicestershire
city: Withington
country: United Kingdom
facility: Pfizer Investigational Site
state: Manchester
city: Northwood
country: United Kingdom
facility: Pfizer Investigational Site
state: Middlesex
city: Birmingham
country: United Kingdom
facility: Pfizer Investigational Site
city: Birmingham
country: United Kingdom
facility: Pfizer Investigational Site
city: Edinburgh
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: Manchester
country: United Kingdom
facility: Pfizer Investigational Site
city: Southhampton
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Kindler HL, Ioka T, Richel DJ, Bennouna J, Letourneau R, Okusaka T, Funakoshi A, Furuse J, Park YS, Ohkawa S, Springett GM, Wasan HS, Trask PC, Bycott P, Ricart AD, Kim S, Van Cutsem E. Axitinib plus gemcitabine versus placebo plus gemcitabine in patients with advanced pancreatic adenocarcinoma: a double-blind randomised phase 3 study. Lancet Oncol. 2011 Mar;12(3):256-62. doi: 10.1016/S1470-2045(11)70004-3.