Clinical trial NCT00769067: A Randomized Trial Of PF-00299804 Taken Orally Versus Erlotinib Taken Orally For Treatment Of Advanced Non-Small Cell Lung Cancer That Has Progressed After One Or Two Prior Chemotherapy Regimen
Official title: A Randomized Phase 2 Trial Of Pf-00299804 Versus Erlotinib For The Treatment Of Advanced Non-small Cell Lung Cancer After Failure Of At Least One Prior Chemotherapy Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: Lung cancer
advanced
second or third line
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-10-08
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare PF-00299804 given orally on continuous schedule to the approved drug, erlotinib, in patients whose non-small cell lung cancer has progressed after chemotherapy; patients will be randomized to receive one of these drugs, and followed for efficacy and tolerance of each.


Eligibility criteria: Inclusion Criteria:

* advanced measurable Non-Small Cell Lung Cancer (NSCLC);
* progressed after 1-2 prior chemotherapy;
* Eastern Cooperative Oncology Group (ECOG) 0-2;
* tissue available for future KRAS/ EGFR testing

Exclusion Criteria:

* prior Epidermal Growth Factor Receptor (EGFR) targeted therapy;
* active or untreated Central Nervous System (CNS) metastases;

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks
Secondary outcomes:
measure: Categorical Summary of Overall Scale Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
timeFrame: Baseline up to Cycle 44 (Week 188)
measure: Categorical Summary of Overall Scale Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13)
timeFrame: Baseline up to Cycle 44 (Week 188)
measure: Dermatology Life Quality Index (DLQI)
timeFrame: Cycle (C) 1 Day (D) 1 (baseline), C1D10-14, D1 of subsequent cycles up to C44
measure: Percentage of Participants With Objective Response
timeFrame: Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks
measure: Best Overall Response (BOR)
timeFrame: Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks
measure: Duration of Response (DR)
timeFrame: Baseline until disease progression or death, assessed at Cycle 2, 3, 4, 5, 6, thereafter every other cycle up to end of treatment (121 weeks), followed by every 8 weeks >284 weeks
measure: Overall Survival (OS)
timeFrame: Baseline until end of treatment (15 August 2014); followed up every 8 weeks after discontinuation from study treatment.
Other outcomes:
measure: Number of Participants With Kirsten Rat Sarcoma (KRAS) and Epidermal Growth Factor Receptor (EGFR) Status and EGFR T790M Mutation
timeFrame: Baseline
measure: Soluble Protein Biomarkers Level
timeFrame: Cycle (C) 1 Day (D) 1 (baseline), D1 of each subsequent cycle up to end of treatment (up to 121 weeks)
measure: Trough Plasma Concentration (Ctrough) of Dacomitinib (PF-00299804)
timeFrame: C1D10-14, C2D1, C3D1, C4D1
Locations:
city: Muscle Shoals
country: United States
facility: Northwest Alabama Cancer Center
state: Alabama
city: Montebello
country: United States
facility: Agajanian Institute of Oncology and Hematology
state: California
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
city: Norwalk
country: United States
facility: Wittingham Cancer Center @ Norwalk Hospital
state: Connecticut
city: Waterbury
country: United States
facility: Medical Oncology & Hematology, P.C.
state: Connecticut
city: Atlanta
country: United States
facility: Winship Cancer Institute at Grady Health Systems
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute, Emory University
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute at Emory University
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute of Emory University
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute, Emory University
state: Georgia
city: Augusta
country: United States
facility: Augusta Oncology Associates, P.C.
state: Georgia
city: Augusta
country: United States
facility: Augusta Oncology Associates, PC
state: Georgia
city: Columbus
country: United States
facility: John B. Amos Cancer Center
state: Georgia
city: Decatur
country: United States
facility: Georgia Cancer Specialists
state: Georgia
city: Gainesville
country: United States
facility: The Longstreet Cancer Center
state: Georgia
city: Macon
country: United States
facility: Central Georgia Cancer Care, P.C.
state: Georgia
city: Marietta
country: United States
facility: Northwest Georgia Oncology Center
state: Georgia
city: Warner Robins
country: United States
facility: Central Georgia Cancer Care, P.C.
state: Georgia
city: Post Falls
country: United States
facility: Kootenai Cancer Center at Post Falls
state: Idaho
city: Post Falls
country: United States
facility: Kootenai Cancer Center
state: Idaho
city: Zion
country: United States
facility: Midwestern Regional Medical Center
state: Illinois
city: Bethesda
country: United States
facility: Center for Blood and Cancer Disorders
state: Maryland
city: Rockville
country: United States
facility: Associates in Oncology/Hematology, PC
state: Maryland
city: Minneapolis
country: United States
facility: University of Minnesota Cancer Center
state: Minnesota
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
city: Clarksburg
country: United States
facility: Oncology/Hematology Associates
state: West Virginia
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: Fitzroy
country: Australia
facility: St. Vincent's Hospital
state: Victoria
city: Geelong
country: Australia
facility: The Andrew Love Cancer Centre,
state: Victoria
city: Wodonga
country: Australia
facility: Border Medical Oncology
state: Victoria
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericordia de Porto Alegre (ISCMPA) - Hospital Santa Rita
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas da PUCRS
state: RS
city: Barretos
country: Brazil
facility: FUNDACAO PIO XII Hospital de Cancer de Barretos
state: SP
city: Sao Paulo
country: Brazil
facility: Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira - ICESP
state: SP
city: Vancouver
country: Canada
facility: BC Cancer Agency - Vancouver Centre
state: British Columbia
city: Barrie
country: Canada
facility: Royal Victoria Hospital
state: Ontario
city: Oshawa
country: Canada
facility: RSM Durham Regional Cancer Centre - Lakeridge Health Oshawa
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
city: Shatin
country: Hong Kong
facility: Department of Clinical Oncology
state: New Territories
city: Tuen Mun
country: Hong Kong
facility: Department of Clinical Oncology, Tuen Mun Hospital
state: New Territories
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University College of Medicine, Yonsei Cancer Center
city: Seoul
country: Korea, Republic of
facility: SamsungMedicalCenter,SungkyunkwanUnivSchoolofMedicine,Div. of Hematology-Oncology, Dep. of Medicine
city: Chrzanow
country: Poland
facility: Medex spolka cywilna
city: Krakow
country: Poland
facility: ¿KardioDent¿
city: Krakow
country: Poland
facility: "Vesalius" Sp. z o.o.
city: Krakow
country: Poland
facility: Zaklad Rentgena i USG Wyrobek spolka jawna
city: Warsaw
country: Poland
facility: Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
city: Warszawa
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej AVI Centrum Medyczne
city: Ponce
country: Puerto Rico
facility: Ponce School of Medicine / CAIMED Center
city: Singapore
country: Singapore
facility: National Cancer Centre
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias I Pujol
state: Barcelona
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llatzer
state: Islas Baleares
city: Barakaldo
country: Spain
facility: Hospital de Cruces
state: Vizcaya
city: La Coruña
country: Spain
facility: Hospital Teresa Herrera
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital, Chest Department
city: Manchester
country: United Kingdom
facility: Christie Hospital NHS Foundation Trust
city: Oxford
country: United Kingdom
facility: Churchill Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Ramalingam SS, O'Byrne K, Boyer M, Mok T, Janne PA, Zhang H, Liang J, Taylor I, Sbar EI, Paz-Ares L. Dacomitinib versus erlotinib in patients with EGFR-mutated advanced nonsmall-cell lung cancer (NSCLC): pooled subset analyses from two randomized trials. Ann Oncol. 2016 Mar;27(3):423-9. doi: 10.1093/annonc/mdv593. Epub 2016 Jan 13.