PF-00299804 in Stage IIIB or Stage IV Non-Small Cell Lung Cancer Not Responding to Standard Therapy for Advanced or Metastatic Cancer
- Registration Number
- NCT01000025
- Lead Sponsor
- NCIC Clinical Trials Group
- Brief Summary
RATIONALE: PF-00299804 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether PF-00299804 is more effective than a placebo in treating patients with advanced non-small cell lung cancer.
PURPOSE: This randomized phase III trial is studying PF-00299804 to see how well it works compared with a placebo in treating patients with stage IIIB or stage IV non-small cell lung cancer that has not responded to standard therapy for advanced or metastatic cancer.
- Detailed Description
OBJECTIVES:
Primary
* To compare overall survival in patients with incurable stage III or IV non-small cell lung cancer receiving PF-00299804 versus placebo after failure of standard therapy for advanced metastatic disease.
Secondary
* To compare overall survival in KRAS-WT patients between the two arms.
* To compare overall survival in EGFR-mutant patients between the two arms.
* To compare progression-free survival between arms.
* To compare objective response rates between arms.
* To estimate time to response and response duration in these patients.
* To evaluate the nature, severity, and frequency of toxicities between arms.
* To compare quality of life between arms.
* To determine the incremental cost-effectiveness and cost-utility ratios for PF-00299804.
* To correlate the expression of tumor and blood markers (at diagnosis) with outcomes and response.
OUTLINE: This is a multicenter study. Patients are stratified according to center, performance status (0 or 1 vs 2 or 3), tobacco use (never vs past or present), best response to prior EGFR tyrosine kinase inhibitor (progressive disease vs other), weight loss (\< 5% vs ≥ 5% or unknown), and ethnicity (East Asian vs other). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Blood, serum, plasma, and tissue samples are collected and examined for biomarkers and gene mutations, and may be banked for future studies.
Patients complete quality-of-life questionnaires EORTC QLQ-C30 and other questionnaires at baseline and then periodically during and after completion of study treatment.
Cost effectiveness and cost utility of PF-00299804 is assessed via the Health Utilities Index (EQ-5D) and the Resource Utilization Assessment periodically.
After completion of study treatment, patients are followed at 4 weeks and then every 12 weeks thereafter.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 720
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PF-00299804 PF-00299804 Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Placebo Placebo Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
- Primary Outcome Measures
Name Time Method Overall Survival 42 Months Median and 95% confidence intervals
- Secondary Outcome Measures
Name Time Method Overall Survival in EGFR-mutant Patients 42 Months Overall survival by EGFR-mutantion subgroups
Overall Survival in KRAS-WT Patients 42 Months Median and 95% confidence intervals of Overall survival in KRAS-WT patients
Objective Response Rate 42 months Response were evaluated in this study using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee. BEST RESPONSE from the start of study treatment until the end of treatment were reported.Objective response rate is the sum of CR + PR divided by the total number of patients in each group.
Number of Participants With Toxicity as Measured by NCI CTCAE Version 4.0 42 Months Number of participants with Toxicities by treatment received according to NCI CTCAE version 4.0
Progression-free Survival 42 Months progression were evaluated using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee
Trial Locations
- Locations (88)
Chonnan National University Hwasun Hospital
🇰🇷Jeongnam, Korea, Republic of
CER - Instituto Medico
🇦🇷Buenos Aires, B1878dvb Bs. As., Argentina
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
COIBA Centro de Oncologia e Investigacion
🇦🇷Berazategui, Provincia De Buenos Aires, Argentina
Frankston Hospital - Peninsula Oncology Centre
🇦🇺Frankston, Victoria, Australia
Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
Austin Hospital
🇦🇺Heidelberg, Victoria, Australia
BCCA - Fraser Valley Cancer Centre
🇨🇦Surrey, British Columbia, Canada
QEII Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada
Dr. H. Bliss Murphy Cancer Centre
🇨🇦St. John's, Newfoundland and Labrador, Canada
Hospital Central De La Fuerza Aerea Del Peru
🇵🇪Lima, Peru
Perpetual Succour Hospital
🇵🇭Cebu City, Philippines
Damic-Fundacion Rusculleda
🇦🇷Cordoba, Argentina
Chi-Mei Foundation Hospital
🇨🇳Tainan, Taiwan
Phillippine General Hospital
🇵🇭Manila, Philippines
Tri-Service General Hospital
🇨🇳Taipei, Taiwan
Makati Medical Center
🇵🇭Makati City, Philippines
China Medical University Hospital
🇨🇳Taichung, Taiwan
Ramathibodi Hospital
🇹🇭Bangkok, Thailand
Siriraj Hospital, Oncology Unit
🇹🇭Bangkok, Thailand
Maharaj Nakorn Chiangmai Hospital
🇹🇭Chiangmai, Thailand
Chulalongkorn University
🇹🇭Bangkok, Thailand
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Allan Blair Cancer Centre
🇨🇦Regina, Saskatchewan, Canada
Ospedale San Raffaele
🇮🇹Milan, Italy
U.O.C. di Oncologia U.L.S.S. 13
🇮🇹Mirano, Italy
Policlinico Umberto I, Universita Sapienza
🇮🇹Rome, Italy
Sir Charles Gairdner Hospital
🇦🇺Perth, Western Australia, Australia
CHUM - Hopital Notre-Dame
🇨🇦Montreal, Quebec, Canada
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada
Western Hospital
🇦🇺Footscray, Victoria, Australia
Intstituto Scientifico Romangnolo
🇮🇹Meldola, Italy
Shapiro, Stafford and Yee
🇺🇸Arcadia, California, United States
Clintell, Inc.
🇺🇸Skokie, Illinois, United States
Centro Medico San Roque
🇦🇷San Miguel de Tucuman, Argentina
Concord Repatriation General Hospital
🇦🇺Concord, New South Wales, Australia
St. George Hospital, Cancer Care Centre
🇦🇺Kogarah, New South Wales, Australia
Prince of Wales Hospital
🇦🇺Randwick, New South Wales, Australia
Royal North Shore Hospital
🇦🇺St. Leonards, New South Wales, Australia
Calvary Mater Newcastle Hospital
🇦🇺Waratah, New South Wales, Australia
Nambour General Hospital
🇦🇺Nambour, Queensland, Australia
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
The Prince Charles Hospital
🇦🇺Chermside, Queensland, Australia
Geelong Hospital
🇦🇺Geelong, Victoria, Australia
Centro de Oncologia e Radioterapia (COR) Mae de Deus
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
ESHO - Empresa de Servicos Hospitalares Ltda.
🇧🇷Brasilia, Sao Paulo, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos
🇧🇷Barretos, SP, Brazil
Oxion Hospital Dia Oncologia LTDA - Oxion
🇧🇷Belo Horizonte, Brazil
Centro de Pesquisa Clinica do Hospital
🇧🇷Porto Alegre, SP, Brazil
Nucleo de Oncologia da Bahia
🇧🇷Salvador, Brazil
BCCA - Abbotsford Centre
🇨🇦Abbotsford, British Columbia, Canada
GRAM - Grupo de Assistencia Medica
🇧🇷Sao Paulo, Brazil
Atlantic Health Sciences Corporation
🇨🇦Saint John, New Brunswick, Canada
Cancer Centre of Southeastern Ontario at Kingston
🇨🇦Kingston, Ontario, Canada
London Regional Cancer Program
🇨🇦London, Ontario, Canada
Lakeridge Health Oshawa
🇨🇦Oshawa, Ontario, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Ottawa Health Research Institute - General Division
🇨🇦Ottawa, Ontario, Canada
Algoma District Cancer Program
🇨🇦Sault Ste. Marie, Ontario, Canada
Health Sciences North
🇨🇦Sudbury, Ontario, Canada
Niagara Health System
🇨🇦St. Catharines, Ontario, Canada
Univ. Health Network-Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Windsor Regional Cancer Centre
🇨🇦Windsor, Ontario, Canada
McGill University - Dept. Oncology
🇨🇦Montreal, Quebec, Canada
A.O. Busto Arsizio - P.O. Saronno
🇮🇹Saronno, VA, Italy
Centro di Riferimento Oncologico - CRO
🇮🇹Aviano, PN, Italy
U.O. di Oncologia Medica Azienda Ospedaliera G Rummo
🇮🇹Benevento, Italy
Ospedale Santa Croce
🇮🇹Fano, Italy
U.O. di Oncologia Ospedale Villa Scassi
🇮🇹Genova, Italy
U.O.C. Terapie Integrate in Oncologia,
🇮🇹Messina, Italy
U.O.C. Oncologia Medica,
🇮🇹Messina, Italy
Dott. Fortunato Ciardiello,Cattedra Oncologia Medica
🇮🇹Napoli, Italy
La Maddalena, Dipartimento Oncologico
🇮🇹Palermo, Italy
Unita Sperimentazioni Cliniche Istituto per lo
🇮🇹Napoli, Italy
UOC Oncologia Medica II Instituto Oncologio Veneto
🇮🇹Padova, Italy
Azienda USL di Piacenza, Ospedale Gugliemimo Salieto
🇮🇹Piacenza, Italy
Azienda Ospedaliera S. Camillo-Forlanin
🇮🇹Rome, Italy
Ospedale Casa Sollievo della Sofferenza
🇮🇹San Giovanni Rotondo, Italy
Ospedale E. Morelli-Sondalo
🇮🇹Sondalo, Italy
Ajou University Hospital
🇰🇷GyeongGi-Do, Korea, Republic of
Yonsei University College of Medicine
🇰🇷Seoul, Korea, Republic of
Seoul Veterans Hospital
🇰🇷Seoul, Korea, Republic of
Auckland City Hospital
🇳🇿Auckland, New Zealand
Hospital Nacional Luis N. Saenz
🇵🇪Lima, Peru
Instituto de Oncologia y Radioterapia de
🇵🇪Lima, Peru
The Catholic University of Korea,
🇰🇷Seoul, Korea, Republic of
BCCA - Vancouver Cancer Centre
🇨🇦Vancouver, British Columbia, Canada