None listed
Conditions
Interventions
GROUP 1 Type of group
Phase of Chemoradiation / Lapatinib: Duration of 7 weeks. This group will be treated with Lapatinib 1500 mg in solution, PO, QD, for 7 weeks. + Cisplatin 100 mg / m2, IV, on days 8, 29 and 50 of the study. If Modulated Intensity Radiation Therapy is administered, then cisplatin should be administered for at least 2 cycles. + Radiotherapy in a conventional fractionation modality, the use of Modulated Intensity Radiation Therapy (IMRT) is also allowed, the dose should not exceed 2.5 Gy per day, it
Phase of Chemoradiation / Lapatinib: Duration of 7 weeks. This group will be treated with Lapatinib Placebo in solution, PO, QD, for 7 weeks. + Cisplatin 100 mg / m2, IV, on days 8, 29 and 50 of the study. If Modulated Intensity Radiation Therapy is administered, then cisplatin should be administered for at least 2 cycles. + Radiotherapy in a conventional fractionation modality, the use of Modulated Intensity Radiation Therapy (IMRT) is also allowed, the dose should not exceed 2.5 Gy per day, it
Sponsors
GLAXOSMITHKLINE PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Decision and ability to sign a written informed consent. 2. Histologically confirmed diagnosis of squamous cell carcinoma of the head and neck. 3. Prior to enrollment, patients should have overexpression of ErbB1 receptors. 4. Patients with disease in stage III and in IVA / IVB stages who must receive chemotherapy with cisplatin and radiation therapy as the primary treatment. 5. Decision and ability to be subjected to a tumor biopsy in the selection. 6. Male or female ≥ 18 years of age. 7. Criteria for female patients or female partners of male patients: A) Without potential to have a family. B) With potential to have family: These patients must have a negative result in the serum test to diagnose pregnancy in the screening and must agree to comply with the following: • Complete abstinence from sexual intercourse from 2 weeks before administering the first dose of the medication under study up to 28 days after the final dose of the study medication; or • Consistent and correct use of acceptable methods for the control of birth 8. Score of 0, 1, or 2 for the performance condition according to the Cooperative Group in Eastern Oncology (ECOG). 9. Patients should have an adequate hematologic, renal and hepatic function. 10. Fraction of left ventricular ejection within the normal institutional ranges, determined with echocardiogram or with the multiple entry acquisition study (MUGA). 11. In ability to swallow tablets whole or swallow a suspension of tablets dissolved in water at the time of inclusion in the study. 12. The life expectancy must be at least 6 months.
Exclusion criteria
Exclusion criteria: 1. Nasopharyngeal tumors, in the paranasal sinuses or in the nasal cavity. 2. Any previous or current treatment for an invasive head and neck cancer of any kind. 3. Concurrent use of inducers or inhibitors of the CYP3A4 system. 4. Patients with a known history of uncontrolled or symptomatic angina, arrhythmias or congestive heart failure. 5. History of another malignancy during the last 5 years. 6. Peripheral neuropathy of one degree ≥2. 7. Pregnant women or women who are breastfeeding. 8. Malabsorption syndrome, a disease that significantly affects gastrointestinal function, which could compromise the absorption of lapatinib.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The complete response will be defined as the disappearance of all target lesions (according to the RECIST criteria) at 6 months after completing the treatment phase with chemoradiation. The target lesions are all measurable head and neck lesions, the maximum diameters of these will be determined by Conventional Computed Tomography and Magnetic Resonance Imaging. Measure:Complete response rate. Timepoints:6 months (24 weeks) after the chemoradiation is completed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:1) Progression free survival: An increase of at least 20% in the sum of the largest diameters of the white lesions or the appearance of one or more new lesion (s) and / or unequivocal progression of the existing non-white lesions will be evaluated. Through CT or MRI. 2) Global survival: Time from randomization to death for any reason. For patients who do not die, the time until death will be counted at the time of the last contact. It will be determined by clinical evaluation. 3) Specific survival: Time from randomization to death from head and neck cancer. It will be determined by clinical evaluation. 4) Local and regional control: Absence of evidence of disease regarding the tumor stage (T) and the position of the lymph nodes (N). Through CT or MRI and clinical evaluation. 5) Relapse at a distance: Time from randomization to the day of the first appearance of distant metastasis. Through CT or MRI. 6) Measurements of the volumetric response: By means of CT or NMR. Measure:1) Survival free of progression at six months and one year after completion of chemotherapy and radiotherapy. 2) Global survival. 3) Specific survival for the disease. 4) Local and regional control. 5) Relapse from a distance. 6) Measurements of the volumetric response of the tumor. Timepoints:CT and MRI studies: Before starting treatment, then every 8 weeks during maintenance, every 12 weeks during the first year of the follow-up period after maintenance and every 24 weeks thereafter, until the progression of the disease. ; Outcome name:Clinical evaluation of adverse events, defined as any unexpected medical situation in a clinical research patient, temporarily associated with the use of a medicinal product, whether or not it is related to the medicinal product. Measure:Adverse events. Timepoints:Day 1, weeks 2, 3, 4, 5, 6 and 7, after the first 8 weeks every 4 weeks for the first year of follow-up and thereafter every 12 weeks. ; Out | — |
Countries
Canada, France, Hungary, India, Netherlands, Peru, Spain, United Kindgdom, United States
Outcome results
None listed