Clinical trial NCT00673049: Trial Of CP-751, 871 And Erlotinib In Refractory Lung Cancer
Official title: Randomized, Open Label, Phase 3 Trial Of Erlotinib Alone Or In Combination With CP-751,871 In Patients With Advanced Non Small Cell Lung Cancer Of Non Adenocarcinoma Histology
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Carcinoma, Large Cell
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell
Carcinoma, Adenosquamous Cell
Keywords: IGR-1R
Non small cell lung cancer
CP-751
871
Figitumumab
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-05-07
Enrollment: 583
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 objective of this study is to test a clinical benefit of the addition of CP 751,871 to erlotinib therapy in patients with advanced NSCLC of non adenocarcinoma histology. The primary endpoint is Overall Survival (OS).

Detailed description: This study was terminated on March 8, 2010 due to an analysis by an independent Data Safety Monitoring Committee (DSMC) indicating that the addition of CP-751,871 \[figitumumab\] to erlotinib \[Tarceva\] would be unlikely to meet the primary endpoint of improving overall survival when compared to erlotinib alone.

This Oncology study continues as terminated, however for ethical reasons some patients, noted with resultant benefit, continue receiving treatment.

Eligibility criteria: Inclusion Criteria:

* Non small cell lung cancer with a primary histology of squamous cell, large cell or adenosquamous carcinoma. At least 1 measurable lesion, as defined by RECIST.

Exclusion Criteria:

* Primary NSCLC adenocarcinoma and its subtypes or unknown/unspecified histology.
* Prior Erlotinib therapy.
* Prior anti IGF IR based investigational therapy.

Primary outcomes:
measure: Overall Survival
timeFrame: Baseline, assessed every cycle until disease progression and then every 4 weeks until death, up to 30.65 months
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Baseline, 6, 9, 12, 15, 18 weeks after randomization, thereafter assessed every 6 weeks until disease progression during treatment (or every 8 weeks until disease progression during off-treatment), up to 29.7 months
measure: Percentage of Participants With Objective Response
timeFrame: Baseline, 6, 9, 12, 15, 18 weeks after randomization, thereafter assessed every 6 weeks until disease progression during treatment (or every 8 weeks until disease progression during off-treatment), up to 29.7 months
measure: Maximum Observed Plasma Concentration (Cmax) for Figitumumab
timeFrame: Cycle 1 (Day 1 [predose], Day 2 [1 hour after end of infusion] ), Cycles 2, 4, 6 (predose), Cycle 5 (predose, 1 hour after end of infusion) for figi plus erlo group; Cycles 1, 2,4 (predose) for erlo, then figi group
measure: Minimum Observed Plasma Trough Concentration (Cmin) for Figitumumab
timeFrame: Cycle 1 (Day 1 [predose], Day 2 [1 hour after end of infusion] ), Cycles 2, 4, 6 (predose), Cycle 5 (predose, 1 hour after end of infusion) for figi plus erlo group; Cycles 1, 2,4 (predose) for erlo, then figi group
measure: Percentage of Participants Reporting Positive for Total Anti-drug Antibodies (ADA)
timeFrame: Cycles 1, 2, 4 (predose), End of Treatment ([EOT] 21-28 days after last dose), about 150 days after last figi dose for figi plus erlo group; Cycles 1, 2, 4 (predose), EOT, about 150 days after last figi dose for erlo, then figi group
measure: Counts of Circulating Tumor Cell (CTC) Expressing Positive Insulin-Like Growth Factor 1 Receptor (IGF-1R)
timeFrame: Baseline, Cycle 2 Day 1 (predose) and EOT (21-28 days after last dose)
measure: Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility at Cycles 2, 3, Then Every Other Cycle and EOT (21-28 Days After Last Dose)
timeFrame: Baseline (Cycle 1 Day 1 predose), Cycles 2, 3 (Day 1), every other cycle and EOT (21-28 days after last dose)
measure: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) at Cycles 2, 3, and Then Every Odd Cycle Starting With Cycle 5 and EOT (21-28 Days After Last Dose)
timeFrame: Baseline (Cycle 1 Day 1 predose), Cycles 2, 3 (Day 1), every odd cycle starting with Cycle 5 and EOT (21-28 days after last dose)
measure: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) Score at Cycles 2, 3, and Then Every Odd Cycle Starting With Cycle 5, and EOT (21-28 Days After Last Dose)
timeFrame: Baseline (Cycle 1 Day 1 predose), Cycles 2, 3 (Day 1), every odd cycle starting with Cycle 5 and EOT (21-28 days after last dose)
Other outcomes:
Locations:
city: Fort Smith
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Hot Springs
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Lakeport
country: United States
facility: Pfizer Investigational Site
state: California
city: Orange
country: United States
facility: Pfizer Investigational Site
state: California
city: Orange
country: United States
facility: Pfizer Investigational Site
state: California
city: Petaluma
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Rosa
country: United States
facility: Pfizer Investigational Site
state: California
city: Thousand Oaks
country: United States
facility: Pfizer Investigational Site
state: California
city: Westlake Valley
country: United States
facility: Pfizer Investigational Site
state: California
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Lafayette
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Hollywood
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Lake City
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Lake City
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Alpharetta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Conyers
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Cumming
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Duluth
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Lake Spivey
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Lawrenceville
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Snellville
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Bloomington
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Peoria
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: Cedar Rapids
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Waterloo
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Bethesda
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: New Albany
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Billings
country: United States
facility: Pfizer Investigational Site
state: Montana
city: Butte
country: United States
facility: Pfizer Investigational Site
state: Montana
city: Lebanon
country: United States
facility: Pfizer Investigational Site
state: New Hampshire
city: Manchester
country: United States
facility: Pfizer Investigational Site
state: New Hampshire
city: Amherst
country: United States
facility: Pfizer Investigational Site
state: New York
city: Bronx
country: United States
facility: Pfizer Investigational Site
state: New York
city: Bronx
country: United States
facility: Pfizer Investigational Site
state: New York
city: Buffalo
country: United States
facility: Pfizer Investigational Site
state: New York
city: Lake Success
country: United States
facility: Pfizer Investigational Site
state: New York
city: Manhasset
country: United States
facility: Pfizer Investigational Site
state: New York
city: New Hyde Park
country: United States
facility: Pfizer Investigational Site
state: New York
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Norman
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Germantown
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Charlottesville
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Charlottesville
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Gloucester
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Glouster
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Newport News
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Williamsburg
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Wenatchee
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Wheeling
country: United States
facility: Pfizer Investigational Site
state: West Virginia
city: Cody
country: United States
facility: Pfizer Investigational Site
state: Wyoming
city: Brasschaat
country: Belgium
facility: Pfizer Investigational Site
city: Mons
country: Belgium
facility: Pfizer Investigational Site
city: Rio de Janeiro
country: Brazil
facility: Pfizer Investigational Site
state: RJ
city: Rio de Janeiro
country: Brazil
facility: Pfizer Investigational Site
state: RJ
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: Higienopolis
country: Brazil
facility: Pfizer Investigational Site
state: Sao Paulo/ Brazil
city: Santo André
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Varna
country: Bulgaria
facility: Pfizer Investigational Site
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Independencia
country: Chile
facility: Pfizer Investigational Site
state: Santiago, RM
city: Kutna Hora
country: Czech Republic
facility: Pfizer Investigational Site
city: Nova Ves pod Plesi
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 8
country: Czech Republic
facility: Pfizer Investigational Site
city: Tabor
country: Czech Republic
facility: Pfizer Investigational Site
city: Rennes
country: France
facility: Pfizer Investigational Site
state: Cedex 9
city: BREST Cedex
country: France
facility: Pfizer Investigational Site
city: La Tronche
country: France
facility: Pfizer Investigational Site
city: Lille
country: France
facility: Pfizer Investigational Site
city: Marseille Cedex 09
country: France
facility: Pfizer Investigational Site
city: Marseille Cedex 20
country: France
facility: Pfizer Investigational Site
city: Saint Pierre la Réunion Cedex
country: France
facility: Pfizer Investigational Site
city: St Priest En Jarez Cedex
country: France
facility: Pfizer Investigational Site
city: Villejuif
country: France
facility: Pfizer Investigational Site
city: Heraklion
country: Greece
facility: Pfizer Investigational Site
state: Crete
city: Larisa
country: Greece
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Matrahaza
country: Hungary
facility: Pfizer Investigational Site
city: Szekesfehervar
country: Hungary
facility: Pfizer Investigational Site
city: Jakarta
country: Indonesia
facility: Pfizer Investigational Site
state: DKI Jakarta
city: Surabaya
country: Indonesia
facility: Pfizer Investigational Site
state: East Java
city: Cork
country: Ireland
facility: Pfizer Investigational Site
city: Dublin 24
country: Ireland
facility: Pfizer Investigational Site
city: Dublin
country: Ireland
facility: Pfizer Investigational Site
city: Avellino
country: Italy
facility: Pfizer Investigational Site
city: Aviano (PN)
country: Italy
facility: Pfizer Investigational Site
city: Cattolica (RN)
country: Italy
facility: Pfizer Investigational Site
city: Modena
country: Italy
facility: Pfizer Investigational Site
city: Orbassano (TO)
country: Italy
facility: Pfizer Investigational Site
city: Padova
country: Italy
facility: Pfizer Investigational Site
city: Rimini
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Gyeonggi-do
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: Riga
country: Latvia
facility: Pfizer Investigational Site
city: Riga
country: Latvia
facility: Pfizer Investigational Site
city: Bydgoszcz
country: Poland
facility: Pfizer Investigational Site
city: Gdansk
country: Poland
facility: Pfizer Investigational Site
city: Krakow
country: Poland
facility: Pfizer Investigational Site
city: Krakow
country: Poland
facility: Pfizer Investigational Site
city: Lublin
country: Poland
facility: Pfizer Investigational Site
city: Olsztyn
country: Poland
facility: Pfizer Investigational Site
city: Olsztyn
country: Poland
facility: Pfizer Investigational Site
city: Rybnik
country: Poland
facility: Pfizer Investigational Site
city: Wodzislaw Sl.
country: Poland
facility: Pfizer Investigational Site
city: Ponce
country: Puerto Rico
facility: Pfizer Investigational Site
city: Cluj-Napoca
country: Romania
facility: Pfizer Investigational Site
state: Cluj
city: Cluj-Napoca
country: Romania
facility: Pfizer Investigational Site
city: Iasi
country: Romania
facility: Pfizer Investigational Site
city: Krasnodar
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: 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: Belgrade
country: Serbia
facility: Pfizer Investigational Site
city: Sremska Kamenica
country: Serbia
facility: Pfizer Investigational Site
city: Ljubljana
country: Slovenia
facility: Pfizer Investigational Site
city: Bloemfontein
country: South Africa
facility: Pfizer Investigational Site
city: Cape Town
country: South Africa
facility: Pfizer Investigational Site
city: Elche
country: Spain
facility: Pfizer Investigational Site
state: Alicante
city: Oviedo
country: Spain
facility: Pfizer Investigational Site
state: Asturias
city: L'hospitalet de Llobregat
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Manresa
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Sabadell
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Girona
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Basel
country: Switzerland
facility: Pfizer Investigational Site
city: Basel
country: Switzerland
facility: Pfizer Investigational Site
city: CH-4101 Bruderholz
country: Switzerland
facility: Pfizer Investigational Site
city: Chur
country: Switzerland
facility: Pfizer Investigational Site
city: Liestal
country: Switzerland
facility: Pfizer Investigational Site
city: Taichung
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Taoyuan County
country: Taiwan
facility: Pfizer Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: Pfizer Investigational Site
city: Donetsk
country: Ukraine
facility: Pfizer Investigational Site
city: Kharkiv
country: Ukraine
facility: Pfizer Investigational Site
city: Kyiv
country: Ukraine
facility: Pfizer Investigational Site
city: Sumy
country: Ukraine
facility: Pfizer Investigational Site
city: Sutton
country: United Kingdom
facility: Pfizer Investigational Site
state: Surrey
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
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Scagliotti GV, Bondarenko I, Blackhall F, Barlesi F, Hsia TC, Jassem J, Milanowski J, Popat S, Sanchez-Torres JM, Novello S, Benner RJ, Green S, Molpus K, Soria JC, Shepherd FA. Randomized, phase III trial of figitumumab in combination with erlotinib versus erlotinib alone in patients with nonadenocarcinoma nonsmall-cell lung cancer. Ann Oncol. 2015 Mar;26(3):497-504. doi: 10.1093/annonc/mdu517. Epub 2014 Nov 13.