None listed
Conditions
Interventions
This group will be treated with Panitumumab, in vials of 20 mg / ml of 10 ml, at a dose of 9 mg / kg, in IV infusion of 1 hour ± 15 minutes, every 21 days, ± 3 days + Cisplatin, at a dose of 100 mg / m2, in IV infusion of 1-2 hours ± 15 minutes, on day 1 of each cycle + 5-Fluorouracil, at a dose of 1000 mg / m2 / day, in IV infusion continued on days 1 to 4 of each cycle. This regimen will be repeated until a total of 6 cycles (each 21-day cycle) or until the patient s withdrawal or appearance o
This group will be treated with Cisplatin, at a dose of 100 mg / m2, in IV infusion of 1-2 hours ± 15 minutes, on day 1 of each cycle + 5-Fluorouracil, at a dose of 1000 mg / m2 / day, IV infusion continues on days 1 to 4 of each cycle. This regimen will be repeated until a total of 6 cycles (each 21-day cycle) or until the patient s withdrawal or appearance of intolerable toxicity.
Sponsors
AMGEN INC.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histological or cytological confirmation of SCCHN or its variants of the oral cavity, oropharynx, hypopharynx or larynx. 2. Diagnosis of metastatic disease and / or recurrent disease after locoregional therapy and determined as incurable by surgery or radiotherapy. 3. Subjects who received radiation as primary therapy are eligible if the locoregional recurrence is in the radiation field and occurred> 6 months after completing radiation therapy. 4. Measurable or non-measurable disease. 5. Degree of ECOG activity of 0 or 1. 6. Male or female ≥18 years of age. 7. Acceptable hematologic function. 8. Acceptable renal function. 9. Acceptable liver function. 10. Acceptable electrolytes. 11. Negative pregnancy test ≤ 72 hours before randomization. 12. The corresponding written informed consent must be obtained before any specific procedure of the study.
Exclusion criteria
Exclusion criteria: 1. Documented or symptomatic central nervous system metastasis. 2. Antecedents of another primary tumor. 3. Subjects whose only site of metastatic disease is a single spiculated pulmonary nodule are assumed to have a second primary pulmonary nodule and are excluded unless there is clear pathological confirmation of primary SCCHN metastasis. 4. Nasopharyngeal carcinoma. 5. Previous systemic treatment for metastatic and / or recurrent SCCHN. 6. Prior systemic chemotherapy for SCCHN as part of the initial multimodal treatment for locally advanced disease if completed <6 months prior to randomization. 7. Previous induction chemotherapy with cisplatin followed by chemoradiotherapy with cisplatin 8. Previous therapy with anti-EGFr antibodies or treatment with small molecules that inhibit EGFr. 9. Subjects that require immunosuppressive agents. 10. Known allergy or hypersensitivity to any of the components of the study medication. 11. Major surgery requiring general anesthesia and a significant incision ≤ 28 days before randomization or minor surgery ≤ 14 days before randomization. 12. Clinically significant cardiovascular disease ≤ 1 year before randomization. 13. History of interstitial lung disease. 14. Symptomatic peripheral neuropathy of grade ≥ 2 based on CTCAE v3.0. 15. Hearing loss of grade ≥ 3 based on CTCAE v3.0 Hearing / Ear. 16. Subjects not recovered from all previous acute toxicity effects related to radiotherapy. 17. Active infection requiring systemic treatment or any uncontrolled infection ≤ 14 days before randomization. 18. Known positive test for infection of human immunodeficiency virus (HIV), hepatitis C virus, chronic hepatitis B infection. 19. Any condition that increases the risk of toxicity. 20. Other investigation procedures are excluded. 21. The subject is currently enrolled in another study of devices or drugs under investigation or spent ≤ 30 days from its completion, or the subject is receiving another investigational agent. 22. Pregnant or nursing woman. 23. Male or female of childbearing age who does not consent to using adequate contraceptive methods. 24. Subject who is unwilling or unable to comply with the requirements of the study. 25. Any kind of disorder that compromises the subject´s ability to give written informed consent and / or to comply with study procedures. 26. Previously randomized within this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Determination of the time from the date of randomization until the date of death. Measure:General survival. Timepoints:At 56 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criterion 1: Time from the date of randomization until the date of disease progression according to a modified version of the RECIST criteria or death. Criterion 2: The incidence of a complete response (CR) or partial response (PR) confirmed according to a modified version of the RECIST criteria. Criterion 3. Time from the first confirmed objective response to the progression of the disease according to a modified version of the RECIST criteria. Criterion 4: Time from the randomization date to the date of disease progression according to a modified version of the RECIST criteria. According to the RECIST criteria, Progressive Disease is defined as: 1) At least 20% increase in the sum of the largest diameters of target lesions. OR 2) Evident progression of non-target lesions. CR is defined as: 1) Disappearance of all target lesions. OR 2) Disappearance of all non-target lesions. PR is defined as: At least 30% decrease in the sum of the largest diameters of target lesions. Measure:1) Survival without progression. 2) Objective response rate. 3) Duration of the response. 4) Time to progression. Timepoints:At 56 months. ; Outcome name:Criterion 1: Clinical evaluation of any harmful medical event in a patient or clinical research subject to which the investigational medication was administered. Criterion 2: Panels of hematology and serum chemistry. Criterion 3: Serum levels of anti-panitumumab human antibodies. Measure:Security: 1) Incidence of Adverse Events (AE). 2) Incidence of significant changes in the laboratory. 3) Formation of human anti-panitumumab antibodies. Timepoints:Criteria 1 and 3: Every 3 weeks and during follow-up. Criterion 2: Day 1 and days 11 ± 3 days of each cycle. ; Outcome name:Criterion 1: Time from the randomization date until the date of the first confirmed objective response. Criterion 2: EUROQOL EQ-5D instrument, for the general evaluation of health. Measure:Tertiar | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, France, Germany, Hungary, India, Ireland, Italy, Japan, Korea South, Mexico, Poland, Portugal, Romania, Russian Federation, Singapore, Sweden, Switzerland, Ukraine, United Kindgdom, United States
Outcome results
None listed