Erlotinib,Radiation and Cisplatin in Patients With Complete Resected Squamous Cell Carcinoma of the Head and Neck

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00442455
Recruitment Status : Completed
First Posted : March 2, 2007
Last Update Posted : September 26, 2016
Information provided by (Responsible Party):
Esther Prats, Grupo de Investigación Clínica en Oncología Radioterapia

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 tolerated dose of the combination of erlotinib, radiation therapy and cisplatin, previously established in a safety trial.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of the Head and Neck Drug: Erlotinib chlorhydrate Drug: Cisplatin Procedure: Radiation therapy Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Trial of Erlotinib, Radiation Therapy, and Cisplatin in Patients With Complete Resected Squamous Cell Carcinoma of the Head and Neck
Study Start Date : January 2006
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Erlotinib, radiotherapy.
There are three cohorts of patients in whom the dose of Erlotinib chlorhydrate(100 and 150 mg) and Cisplatin (30 and 40 mg / m2) will be increase, and the doses of Radiation therapy being fixed (63 Gy during 5 days a week during 7 weeks)
Drug: Erlotinib chlorhydrate
150 mg/day for 7 weeks
Other Name: Erlotinib clorhidrate
Drug: Cisplatin
30 mg/m2 i.v. weekly for 7 weeks
Other Name: Cisplatino
Procedure: Radiation therapy
63 Gy, five days a week, for 7 weeks

Primary Outcome Measures :
  1. Determinate the maximum tolerated dose (PHASE I) [ Time Frame: 17/MAR/08 ]
  2. Progression free survival (PHASE II) [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. DLT (PHASE I) [ Time Frame: 17/MAR/08 ]
  2. Overall survival and locoregional progression free survival (PHASE II) [ Time Frame: 5 years ]

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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:

    1. Pathological T3-4 tumor stage, apart from T3N0 of the larynx with negative margins
    2. Pathological N2-3 nodal stage.
    3. 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:

    1. Adequate bone marrow reserve: ANC > 1,5 x 10(9) cells/L; Platelet count > 100 x 10(9) cells/L; Hemoglobin > 9 g/dL
    2. Liver function: Bilirubin < 1.5 x ULN; Alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) < 3.0 x ULN
    3. Renal function: calculated creatinine clearance (CrCl) > 60ml/min or Creatinine (Cr) < 1.5 ULN of the reference laboratory.
    4. 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00442455

Hospital de Navarra
Pamplona, Navarra, Spain, 31008
Hospital Clínico San Carlos
Madrid, Spain, 28003
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007
Hospital Universitario Clínica Puerta de Hierro
Madrid, Spain, 28035
Hospital Regional Universitario Carlos Haya
Málaga, Spain, 29010
Sponsors and Collaborators
Grupo de Investigación Clínica en Oncología Radioterapia
Study Director: Felipe Calvo Manuel, Dr. Hospital General Universitario Gregorio Marañón
Principal Investigator: Alejandro de la Torre Tomás, Dr. Hospital Universitario Clínica Puerta de Hierro
Principal Investigator: Manuel de las Heras González, Dr. Hospital Clínico San Carlos
Principal Investigator: Ismael Herruzo Cabrera, Dr. Hospital Regional Universitario Carlos Haya
Principal Investigator: Fernando Arias de la Vega, Dr. Hospital de Navarra

Responsible Party: Esther Prats, Oncologist, Grupo de Investigación Clínica en Oncología Radioterapia Identifier: NCT00442455     History of Changes
Other Study ID Numbers: ML 18729
First Posted: March 2, 2007    Key Record Dates
Last Update Posted: September 26, 2016
Last Verified: September 2016

Keywords provided by Esther Prats, Grupo de Investigación Clínica en Oncología Radioterapia:
Head Neck Carcinoma Erlotinib

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action