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

NCT00442455 | Completed Phase 3 DMC

• 1 other identifier: ML 18729
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 5

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.

Conditions

Squamous Cell Carcinoma of the Head and Neck

Keywords

Head Neck Carcinoma Erlotinib

Outcome Measures

Primary Outcomes (2)

• Determinate the maximum tolerated dose (PHASE I)

  17/MAR/08

• Progression free survival (PHASE II)

  5 years

Secondary Outcomes (2)

• DLT (PHASE I)

  17/MAR/08

• Overall survival and locoregional progression free survival (PHASE II)

  5 years

Study Arms (1)

Erlotinib, radiotherapy.

EXPERIMENTAL

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; Drug: Cisplatin; Procedure: Radiation therapy

Interventions

Erlotinib chlorhydrate DRUG

150 mg/day for 7 weeks

Also known as: Erlotinib clorhidrate

Erlotinib, radiotherapy.

Cisplatin DRUG

30 mg/m2 i.v. weekly for 7 weeks

Also known as: Cisplatino

Erlotinib, radiotherapy.

Radiation therapy PROCEDURE

63 Gy, five days a week, for 7 weeks

Erlotinib, radiotherapy.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histological proof of epidermoid carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx, treated with surgical resection with curative intent.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Grupo de Investigación Clínica en Oncología Radioterapia: lead

Study Sites (5)

Hospital de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Clínico San Carlos

Madrid, 28003, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Universitario Clínica Puerta de Hierro

Madrid, 28035, Spain

Location

Hospital Regional Universitario Carlos Haya

Málaga, 29010, Spain

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Cisplatin; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Therapeutics

Study Officials

• Felipe Calvo Manuel, Dr.

  Hospital General Universitario Gregorio Marañón

  STUDY DIRECTOR

• Alejandro de la Torre Tomás, Dr.

  Hospital Universitario Clínica Puerta de Hierro

  PRINCIPAL INVESTIGATOR

• Manuel de las Heras González, Dr.

  Hospital San Carlos, Madrid

  PRINCIPAL INVESTIGATOR

• Ismael Herruzo Cabrera, Dr.

  Hospital Regional Universitario Carlos Haya

  PRINCIPAL INVESTIGATOR

• Fernando Arias de la Vega, Dr.

  Hospital de Navarra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oncologist

Study Record Dates

• First Submitted: March 1, 2007
• First Posted: March 2, 2007
• Study Start: January 1, 2006
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: June 6, 2019

Record last verified: 2019-05

Locations

ES (5)