apatinib Versus Placebo Given Concurrently With Cisplatin And Radiotherapy In Patients With Unresected Head And Neck Cancer
- Conditions
- -C444 Skin of scalp and neckSkin of scalp and neckC444
- Registration Number
- PER-053-06
- Lead Sponsor
- GLAXOSMITHKLINE PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 4
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>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.<br>Measure:Complete response rate.<br>Timepoints:6 months (24 weeks) after the chemoradiation is completed.<br>
- Secondary Outcome Measures
Name Time Method