Status:
COMPLETED
Erlotinib,Radiation and Cisplatin in Patients With Complete Resected Squamous Cell Carcinoma of the Head and Neck
Lead Sponsor:
Grupo de Investigación Clínica en Oncología Radioterapia
Conditions:
Squamous Cell Carcinoma of the Head and Neck
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to determinate the free-progression interval in patients with surgically resected locally advanced squamous cell carcinoma of head and neck treated with the maximum tolerat...
Detailed Description
Phase I: 3 cohorts of 3-6 patients, patients will received: * Erlotinib 100-150 mg/day po for 7 weeks. * Cisplatin 30-40 mg/m2 iv weekly for 7 weeks. * Radiation therapy 63 Gy, five days a week, for...
Eligibility Criteria
Inclusion
- Patients with histological proof of epidermoid carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx, treated with surgical resection with curative intent.
- Surgical resection must have taken place within 8 weeks prior to the patient's inclusion in the study.
- In those patients having clinical regional lymph node involvement radical neck dissection is mandatory. However, radical neck dissection is not an inclusion criterion in patients staged as N0.
- Age 18-70 years.
- Anticipated life expectancy of ≥ 12 weeks.
- Patients should have at least one of the following criteria:
- Pathological T3-4 tumor stage, apart from T3N0 of the larynx with negative margins
- Pathological N2-3 nodal stage.
- Unfavorable pathological findings such as extranodal spread, positive resection margins, perineural and/or vascular involvement.
- Written informed consent given by the patient.
- Therapeutic compliance of the patient and geographical proximity to the hospital to facilitate appropriate follow-up.
- ECOG 0-1.
- No distant metastatic disease.
- Adequate organ function according to the following criteria:
- Adequate bone marrow reserve: ANC \> 1,5 x 10(9) cells/L; Platelet count \> 100 x 10(9) cells/L; Hemoglobin \> 9 g/dL
- Liver function: Bilirubin \< 1.5 x ULN; Alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) \< 3.0 x ULN
- Renal function: calculated creatinine clearance (CrCl) \> 60ml/min or Creatinine (Cr) \< 1.5 ULN of the reference laboratory.
- Serum calcium and alkaline phosphatase must be normal.
- Women of child bearing potential must have a negative pregnancy test within the 48h prior to the start of the treatment.
- Patients of both genders at a fertile age must follow effective contraceptive measures.
- Absence of symptomatic coronary artery disease or acute myocardial infarction within 6 months prior to study.
- Patients capable of oral deglutition or requiring gastrostomy.
- No problems of intestinal transit such as malabsorption syndrome, chronic inflammatory bowel disease and other diseases, which might impair drug absorption
Exclusion
- Histology other than squamous cell carcinoma.
- Presence of macroscopic residual disease.
- Previous treatment with chemotherapy or radiotherapy or EGFR-targeted agents.
- Incomplete resection of the primary tumor or incomplete neck dissection.
- Patients being diagnosed with any other malignant disease, excluding resected nonmelanoma skin cancer or resected uterine cervix carcinoma.
- Pregnant or nursing women.
- Active infection.
- Concomitant severe illness (according to the opinion of the investigator) or whose estimated survival for this concomitant pathology is lower than that estimated for the neoplasm disease.
- Uncontrolled psychiatric illness.
- Inability to take oral medication, requiring intravenous feeding or prior surgical procedures affecting absorption or having active peptic ulcer.
- Impossibility to appropriate follow-up.
- Evidence of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding suggesting a condition that contraindicates the use of the study medication (erlotinib, cisplatin, radiotherapy), which might interfere with the analysis of the results or increase the risk of treatment complications.
- Any known significant ophthalmologic abnormalities, including severe xerophthalmia, keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratopathy or other abnormalities, which may increase the risk of corneal epithelial damage (the use of contact lenses during the study may increase the risk of corneal damage and its use is strongly discouraged. Those patients still using contact lenses will need a closer ophthalmologic follow-up.
- Frequent vomiting or medical disorder impairing swallowing of drugs
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00442455
Start Date
January 1 2006
End Date
August 1 2015
Last Update
June 6 2019
Active Locations (5)
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1
Hospital de Navarra
Pamplona, Navarre, Spain, 31008
2
Hospital Clínico San Carlos
Madrid, Spain, 28003
3
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007
4
Hospital Universitario Clínica Puerta de Hierro
Madrid, Spain, 28035