None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with Lapatinib 1500 mg QD PO for a minimum of 2 weeks up to a maximum of 6 weeks. After this the patients will continue with the standard therapy that will consist of conventional radiotherapy in fractionation with a dose greater than or equal to 66 Gy in total and a chemotherapy based on cisplatin and carboplatin.
Group name:GROUP 2 Type of group
This group will be treated with Lapatinib Placebo QD PO for a minimum of 2 weeks up to a maximum of 6 weeks. After this the patients will continue with the standard therapy that will consist of conventional radiotherapy in fractionation with a dose greater than or equal to 66 Gy in total and a chemotherapy based on cisplatin and carboplatin.
Sponsors
GLAXOSMITHKLINE BIOLOGICALS,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient who wants and is able to sign an informed consent. 2. Histological or cytologically confirmed diagnosis of squamous cell head and neck carcinoma. 3. Patients with stage III and IVA disease will be eligible if they are scheduled to receive chemoradiation therapy as the primary treatment. 4. Patients who wish and are able to have a biopsy of the tumor in the selection and to have a second biopsy of the tumor during the administration of lapatinib / placebo. 5. Men or women> 18 years of age. 6. Women without potential to have family or potential to have family if they have a negative result in a serum test to diagnose pregnancy and if they use acceptable contraceptive methods. 7. Condition of performance according to the ECOG in 0,1 or 2. 8. Patients should have adequate haematological, renal and hepatic function. 9. Fraction of left ventricular ejection within normal ranges. 10. Ability to swallow a whole tablet or swallow a suspension of the tablet dissolved in water. 11. Life expectancy of at least 6 months.
Exclusion criteria
Exclusion criteria: 1. Patients with tumors of the paranasal sinuses and the nasal cavity. 2. Patients who have received prior systemic chemotherapy, administered as a curative attempt. 3. Patients who have received prior radiotherapy. 4. Previous or concurrent treatment with tyrosine kinase inhibitors. 5. Use of an investigational agent within 30 days or 5 previous half-lives, whichever is more prolonged, before administering the first dose of lapatinib. 6. Concurrent use of inducers or inhibitors of the CYP3A4 system. 7. Patients with a known history of uncontrolled or symptomatic angina, arrhythmias or congestive heart failure. 8. History of another malignancy during the previous 5 years, with the exception of recently resected basal or squamous cell skin cancer or carcinoma in situ that has been successfully treated. 9. Remote metastasis. 10. Men or women with potential to have a family who are sexually active, if they do not accept to use an effective method of contraception. 11. Pregnant women or breastfeeding. 12. Malabsorption syndrome, a disease that significantly affects gastrointestinal function, which could affect the absorption of lapatinib. 13. History of allergic reactions to diuretics or appropriate antiemetics to be administered with a platinum-based chemotherapy. 14. The investigator considers that it is not appropriate for the patient to participate in the study as a result of the medical interview, physical exams, or screening investigations. 15. Patients taking any prohibited medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Realization of panendoscopy and taking of tumor biopsies. Measure:Percentage of apoptosis / necrosis in samples after two to six weeks of treatment. Timepoints:Before treatment and between days 14 and 17 of the treatment, preferably. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation Imaging: CT, NMR, PET, DCR-MRN. Peripheral blood sample of circulating tumor cells. Measure:Cell proliferation rate. Number of circulating tumor cells. Clinical and radiographic magnitude. Timepoints:Clinical evaluation: During the 2-6 weeks of treatment, week 4 of chemo-irradiation, at the end of treatment and at weeks 6 and 8 of follow-up. Imaging: During the 2-6 weeks of treatment, week 4 of chemo-irradiation. Circulating tumor cells: During the 2-6 weeks of treatment duration, week 4 of chemo-irradiation. ; Outcome name:Biomarkers: ErbBl, ErbB2, 3 and 4, their phosphorylated counterparts, also the markers MAPK, PI3K / AKT, p53, pl6, Ki-67. Proteomic profile. Blood Sample for Transcriptomics. Sample for Pharmacogenetics: Direct methods (sequencing of genes related to cancer) or methods that encompass the genome (comparative hybridization of series of genomes). Measure:Tumor biomarkers. Identification of new tumor biomarkers. Intratumoral genetic changes. Timepoints:Biomarkers, Proteomic profile, Transcriptomics: Before starting treatment, during the 2-6 weeks of treatment, at the end of treatment. Sample for Pharmacogenetics: At the first available opportunity during treatment. ; Outcome name:Clinical evaluation: Physical examination and registry of adverse events. 12-lead ECG. Performance Condition according to the ECOG. Serum test to diagnose pregnancy. MUGA or ECHO. Chest x-ray Panels of hematology and serum chemistry. Calculation of Creatinine Clearance. Measure:Toxicity and safety. Timepoints:Clinical evaluation, ECOG: During the 2-6 weeks of treatment, week 4 of chemo-irradiation, at the end of treatment and at weeks 6 and 8 of follow-up. 12-lead ECG, pregnancy test, chest x-ray: Before starting the study and at the end of the treatment. MUGA or ECHO, pannels of hematology and serum chemistry, creatinine clearance: Dur | — |
Countries
Brazil, France, Greece, India, Peru, Spain, United Kindgdom
Outcome results
None listed