A Study Of Lapatinib Versus Placebo Followed By Chemoradiation In Patients With Locally Advanced Head And Neck Cancer
- Conditions
- -C444 Skin of scalp and neckSkin of scalp and neckC444
- Registration Number
- PER-001-06
- Lead Sponsor
- GLAXOSMITHKLINE BIOLOGICALS,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Realization of panendoscopy and taking of tumor biopsies.<br><br>Measure:Percentage of apoptosis / necrosis in samples after two to six weeks of treatment.<br>Timepoints:Before treatment and between days 14 and 17 of the treatment, preferably.<br>
- Secondary Outcome Measures
Name Time Method