Status:
COMPLETED
PF-00299804 in Patients With Head and Neck Squamous Cell Carcinoma
Lead Sponsor:
Yonsei University
Conditions:
Head Neck Cancer Squamous Cell Metastatic
Head Neck Cancer Squamous Cell Recurrent
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Epidermal growth factor receptor (EGFR) is often over-expressed, and have been related to poor prognosis in patients with HNSCC. EGFR targeting strategies showed clinical anti-tumor efficacy in patien...
Eligibility Criteria
Inclusion
- Histologically confirmed squamous cell carcinoma of head and neck
- Age ≥ 18
- ECOG PS 0-2
- Documented progressive disease after platinum-based systemic chemotherapy (either cisplatin or carboplatin) with or without cetuximab
- At least one bidimensionally measurable disease
- Adequate organ function for treatment
- Availability of tumor tissue for molecular analysis (archival or rebiopsy tissue)
Exclusion
- Nasopharyngeal carcinoma
- Eligibility for local therapy (surgery or radiotherapy)
- Previous treatment with small molecule EGFR tyrosine kinase inhibitors
- More than one systemic chemotherapy
- Any major operation or irradiation within 4 weeks of baseline disease assessment
- Any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug
- CNS metastasis with continuous corticosteroid use within 4 weeks of baseline disease assessment
- Patients with known interstitial lung disease
- Patients with uncontrolled or significant cardiovascular disease (AMI within 12 months, Unstable angina within 6 months, NYHA Class III, IV Congestive heart failure or left ventricular ejection fraction below local institutional lower limit of normal or below 45%, Congenital long QT syndrome, Any significant ventricular arrhythmia, Any uncontrolled second or third degree heart block, Uncontrolled hypertension)
- Concomitant malignancy (except adequately treated basal cell cancer of skin or cervical cancer in situ)
- Pregnant or breast-feeding women
- Other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into this trial.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01449201
Start Date
October 1 2011
End Date
March 1 2014
Last Update
September 30 2014
Active Locations (6)
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1
Severance Hospital
Seoul, Seoul, South Korea, 120-752
2
Chilgok Kyungpook National University Hospital
Daegu, South Korea
3
Dongsan Medical Center
Daegu, South Korea
4
Asan Medical Center
Seoul, South Korea