PF-00299804 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
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|ClinicalTrials.gov Identifier: NCT01000025|
Recruitment Status : Completed
First Posted : October 22, 2009
Results First Posted : October 27, 2014
Last Update Posted : August 12, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: PF-00299804 Drug: Placebo||Phase 3|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||720 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Double Blind Placebo Controlled Randomized Trial of PF-804 in Patients With Incurable Stage IIIB/IV Non-Small Cell Lung Cancer After Failure of Standard Therapy for Advanced or Metastatic Disease|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||November 2015|
Active Comparator: PF-00299804
Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
PF-804 45 mg PO, daily
Placebo Comparator: Placebo
Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Placebo 45 mg PO, daily
- Overall Survival [ Time Frame: 42 Months ]Median and 95% confidence intervals
- Overall Survival in KRAS-WT Patients [ Time Frame: 42 Months ]Median and 95% confidence intervals of Overall survival in KRAS-WT patients
- Overall Survival in EGFR-mutant Patients [ Time Frame: 42 Months ]Overall survival by EGFR-mutantion subgroups
- Progression-free Survival [ Time Frame: 42 Months ]progression were evaluated using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee
- Objective Response Rate [ Time Frame: 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 [ Time Frame: 42 Months ]Number of participants with Toxicities by treatment received according to NCI CTCAE version 4.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01000025
Show 89 Study Locations
|Study Chair:||Peter Ellis, MD||Margaret and Charles Juravinski Cancer Centre|
|Study Chair:||Penny Bradbury, MD||NCIC Clinical Trials Group|
|Study Chair:||Michael Millward, MD||Sir Charles Gairdner Hospital - Nedlands|