Clinical trial NCT00548093: PF-00299804 As A Single Agent, In Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Chemotherapy And Erlotinib
Official title: A PHASE 2, OPEN-LABEL, TWO ARM TRIAL TO EVALUATE THE EFFICACY OF PF-00299804 IN PATIENTS WITH ADVANCED NSCLC AFTER FAILURE OF AT LEAST ONE PRIOR CHEMOTHERAPY REGIMEN AND FAILURE OF PRIOR TREATMENT WITH ERLOTINIB
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non Small Cell Lung
Keywords: non-small cell lung cancer
advanced
previously treated
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-10-23
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

Brief summary: To assess the antitumor efficacy measured by the objective response rate of oral PF-00299804 taken daily, as single agent in patients with advanced NSCLC who failed at least one chemotherapy + erlotinib.


Eligibility criteria: Inclusion Criteria:

* Advanced Non-Small Cell Lung Cancer (NSCLC)
* Prior treatment with and failure of at least one regimen of chemotherapy and erlotinib.
* Prior treatment with no more than two chemotherapy regimens, including adjuvant or combined modality treatment.
* Measurable disease .
* Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
* Tissue available for KRAS/ EGFR testing
* Creatinine clearance \> 40 cc/min or serum creat \< 1.5 x ULN

Exclusion Criteria:

* Chemotherapy
* Radiotherapy
* Biological or investigational agents within 4 weeks of baseline disease assessment.
* Patients who lack of tolerance of erlotinib therapy.

Primary outcomes:
measure: Best Overall Response (BOR) in Participants With Adenocarcinoma Histology
timeFrame: Baseline, end of every even-numbered cycle up to end of treatment (Day 936)
Secondary outcomes:
measure: Best Overall Response (BOR) in Participants With Non-Adenocarcinoma Histology
timeFrame: Baseline, end of every even-numbered cycle up to end of treatment (Day 936)
measure: Duration of Response (DR)
timeFrame: Baseline, end of every even-numbered cycle up to end of treatment (Day 936)
measure: Percent Probability of Progression-free Survival (PFS) at Month 6
timeFrame: Up to 6 months after the start of study medication
measure: Percent Probability of Overall Survival at Months 6 and 12
timeFrame: Months 6, 12
measure: Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)]
timeFrame: 0.5-2, 3-5, 6-8, 22-26 hours post dose on Day 1 of Cycle 1
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0.5-2, 3-5, 6-8, 22-26 hours post dose on Day 1 of Cycle 1
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 0.5-2, 3-5, 6-8, 22-26 hours post dose on Day 1 of Cycle 1
measure: Human Epidermal Growth Factor-2 (HER-2) and Epidermal Growth Factor Receptor (EGFR) Levels in Serum
timeFrame: Baseline [pre-dose on Cycle 1 Day 1 (C1D1)], then pre-dose on Day 1 of each cycle, end of treatment (Day 936)
measure: Number of Participants With Human Epidermal Growth Factor Family (HER-Family) and Kirsten Rat Sarcoma (KRAS) Gene Mutation Status From Free Tumor Deoxy- Ribonucleic Acid (DNA) in Blood at Screening
timeFrame: Screening
measure: European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score
timeFrame: Baseline (C1D1), C2D1 thereafter every subsequent cycle up to C43
measure: European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score
timeFrame: Baseline (C1D1), C2D1 thereafter every subsequent cycle up to C43
measure: Dermatology Life Quality Index (DLQI) Score
timeFrame: Baseline (C1D1), C2D1 thereafter every subsequent cycle up to C43
measure: Percentage of Participants With Progression-free Survival (PFS)
timeFrame: Month 6
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Pasadena
country: United States
facility: City of Hope Medical Group
state: California
city: South Pasadena
country: United States
facility: City of Hope South Pasadena Cancer Center
state: California
city: Aurora
country: United States
facility: Rocky Mountain Lions Eye Institute
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital, Anschutz Cancer Pavilion
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital, Anschutz Inpatient Pavilion
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Atlanta
country: United States
facility: Grady Health Systems
state: Georgia
city: Atlanta
country: United States
facility: Emery University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory Clinic
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute
state: Georgia
city: Bethesda
country: United States
facility: CCR, National Cancer Institute
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute/Wayne State University
state: Michigan
city: Farmington Hills
country: United States
facility: Lawrence and Idell Weisberg Cancer Treatment Center
state: Michigan
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Reckamp KL, Giaccone G, Camidge DR, Gadgeel SM, Khuri FR, Engelman JA, Koczywas M, Rajan A, Campbell AK, Gernhardt D, Ruiz-Garcia A, Letrent S, Liang J, Taylor I, O'Connell JP, Janne PA. A phase 2 trial of dacomitinib (PF-00299804), an oral, irreversible pan-HER (human epidermal growth factor receptor) inhibitor, in patients with advanced non-small cell lung cancer after failure of prior chemotherapy and erlotinib. Cancer. 2014 Apr 15;120(8):1145-54. doi: 10.1002/cncr.28561. Epub 2014 Feb 5.