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)
Shapiro, Stafford and Yee
🇺🇸Arcadia, California, United States
Clintell, Inc.
🇺🇸Skokie, Illinois, United States
CER - Instituto Medico
🇦🇷Buenos Aires, B1878dvb Bs. As., Argentina
COIBA Centro de Oncologia e Investigacion
🇦🇷Berazategui, Provincia De Buenos Aires, Argentina
Damic-Fundacion Rusculleda
🇦🇷Cordoba, Argentina
Centro Medico San Roque
🇦🇷San Miguel de Tucuman, Argentina
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
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
Scroll for more (78 remaining)Shapiro, Stafford and Yee🇺🇸Arcadia, California, United States