Clinical trial NCT00768664: Open-Label Trial Of Oral PF-00299804 By Continuous Dosing In Patients With Recurrent Or Metastatic Head And Neck Squamous Cell Cancer
Official title: CLINICAL PHASE 2 MULTICENTER TRIAL OF PF-00299804 IN PATIENTS WITH RECURRENT OR METASTATIC SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Neoplasms
Keywords: recurrent or metastatic squamous cell cancer of the Head and Neck; no prior systemic therapy for recurrence
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-10-08
Enrollment: 69
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: This study will investigate the safety and efficacy of oral PF-00299804 in patients who have not yet undergone any other drug treatment for recurrent and/ or metastatic head and neck squamous cell cancer.


Eligibility criteria: Inclusion Criteria:

* Recurrent or metastatic Squamous Cell Cancer of the Head and Neck;
* Measurable disease;
* Eastern Cooperative Oncology Group (ECOG) 0-1 in Stage 1 = first 23 patients;
* Eastern Cooperative Oncology Group (ECOG) 0-2 in Stage 2 = 33 patients;

Exclusion Criteria:

* prior therapy for recurrence;
* platelets \< 75,000;
* prior Epidermal Growth Factor Receptor (EGFR) therapy;
* interstitial lung disease;
* primary of nasopharynx

Primary outcomes:
measure: Percentage of Participants With Objective Response (OR) of Complete Response (CR) or Partial Response (PR)
timeFrame: Baseline up to 18 months
Secondary outcomes:
measure: Duration of Response (DR)
timeFrame: Baseline up to 18 months
measure: Duration of Stable Disease (SD)
timeFrame: Baseline up to 18 months
measure: Progression-Free Survival (PFS)
timeFrame: Baseline up to 18 months
measure: Progression-Free Survival (PFS) at 6 Months and at 1 Year
timeFrame: Baseline up to 52 weeks
measure: Overall Survival (OS)
timeFrame: Baseline up to 18 months
measure: Overall Survival at 6 Months and 1 Year
timeFrame: Baseline up to Week 52
measure: Trough Plasma Concentrations (Ctrough) of Dacomitinib After Repeat Dosing
timeFrame: Predose on Day 1 of Cycles 2, 3, and 4 and predose on Day 8 of Cycle 1
measure: Ctrough of Dacomitinib After Repeat Dosing In Participants Requiring Administration of Dacomitinib With a Feeding Tube
timeFrame: Predose on Day 1 of Cycles 2, 3, and 4 and predose on Day 8 of Cycle 1
measure: Maximum Observed Plasma Concentration (Cmax) In Participants Requiring Administration of Dacomitinib With a Feeding Tube
timeFrame: Cycle 1 Day 1 at predose and 1, 2, 4, 6, 8, 10, and 24 hours postdose
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) In Participants Requiring Administration of Dacomitinib With a Feeding Tube
timeFrame: Cycle 1 Day 1 at predose and 1, 2, 4, 6, 8, 10, and 24 hours postdose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) In Participants Requiring Administration of Dacomitinib With a Feeding Tube
timeFrame: Cycle 1 Day 1 at predose and 1, 2, 4, 6, 8, 10, and 24 hours postdose
measure: Plasma Decay Half-Life (t1/2)
timeFrame: Cycle 1 Day 1 at predose and 1, 2, 4, 6, 8, 10, and 24 hours postdose
measure: Correlation Between Biomarkers Status and Best Overall Response
timeFrame: Baseline up to 18 months
measure: H-Score at Baseline and Post-baseline for Paired Biopsy Biomarkers
timeFrame: Baseline up to 18 Months
measure: H-Score at Ratio to Baseline for Paired Biopsy Biomarkers
timeFrame: Baseline up to 18 Months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Cancer Agency, Vancouver Centre
state: British Columbia
city: Vancouver
country: Canada
facility: Fairmont Medical Building
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Centre
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre: Odette Cancer Center
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: Hopital Notre-dame du CHUM - Oncology Center
state: Quebec
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Psyrri A, Rampias T, Vermorken JB. The current and future impact of human papillomavirus on treatment of squamous cell carcinoma of the head and neck. Ann Oncol. 2014 Nov;25(11):2101-2115. doi: 10.1093/annonc/mdu265. Epub 2014 Jul 23.