PHASE I/II TRIAL OF ERLOTINIB, RADIATIONTHERAPY, AND CISPLATIN IN PATIENTS WITH COMPLETE RESECTED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECKEnsayo Fase I/II de Erlotinib en combinación con radioterapia y cisplatino en pacientes con carcinoma epidermoide de cabeza y cuello localmente avanzado resecado quirúrgicamente

• Conditions: PATIENTS WITH COMPLETE RESECTED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK; MedDRA version: PTLevel: 7.1Classification code 10014987

• Registration Number: EUCTR2005-001506-29-ES
• Lead Sponsor: Group of Clinical Investigation in Radiotherapy Oncology (GICOR)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-13
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. - Patients with histological proof of epidermoid carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx, treated with surgical resection with curative intent.
2. - Surgical resection must have taken place within 8 weeks prior to the patient’s inclusion in the study.
3. - 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.
4. - Age 18-70 years.
5. - Anticipated life expectancy of = 12 weeks.
6. - 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.
7. - Written informed consent given by the patient.
8. - Therapeutic compliance of the patient and geographical proximity to the hospital to facilitate appropriate follow-up.
9. - ECOG 0-1.
10. - No distant metastatic disease.
11. - Adequate organ function according to the following criteria:
a. Adequate bone marrow reserve: ANC > 1,5 x 10(9) cells/L; Platelet count > 100 x 10(9) cells/L; Hemoglobin > 9 g/dL
b. Liver function: Bilirubin < 1.5 x ULN; Alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) < 3.0 x ULN
c. Renal function: calculated creatinine clearance (CrCl) > 60ml/min or Creatinine (Cr) < 1.5 ULN of the reference laboratory.
d. Serum calcium and alkaline phosphatase must be normal.
12. - Women of child bearing potential must have a negative pregnancy test within the 48h prior to the start of the treatment.
13. - Patients of both genders at a fertile age must follow effective contraceptive measures.
14. - Absence of symptomatic coronary artery disease or acute myocardial infarction within 6 months prior to study.
15. - Patients capable of oral deglutition or requiring gastrostomy.
16. - No problems of intestinal transit such as malabsorption syndrome, chronic inflammatory bowel disease and other diseases, which might impair drug absorption
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. - Histology other than squamous cell carcinoma.
2. - Presence of macroscopic residual disease.
3. - Previous treatment with chemotherapy or radiotherapy or EGFR-targeted agents.
4. - Incomplete resection of the primary tumor or incomplete neck dissection.
5. - Patients being diagnosed with any other malignant disease, excluding resected nonmelanoma skin cancer or resected uterine cervix carcinoma.
6. - Pregnant or nursing women.
7. - Active infection.
8. - 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.
9. - Uncontrolled psychiatric illness.
10. - Inability to take oral medication, requiring intravenous feeding or prior surgical procedures affecting absorption or having active peptic ulcer.
11. - Impossibility to appropriate follow-up.
12.- 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, cisplatine, radiotherapy), which might interfere with the analysis of the results or increase the risk of treatment complications.
13.- 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.
14. - Frequent vomiting or medical disorder impairing swallowing of drugs.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified