Head and Neck Squamous Cell Carcinoma (HNSCC).
Conditions
Interventions
Intervention 1: Intervention group: Cetuximab bio-similar of Zistdaru Danesh Co. ® (100 mg/20 ml vial) which is administered intravenously in the first, fourth, seventh and tenth weeks together with D
Sponsors
Zistdaru Danesh Co.
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Patients older than 18 years and less than 85 years Confirmed pathology of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, paranasal sinus cancer or larynx Locally advanced or metastatic or recurrent disease that are not candidates for local treatment At least one measurable lesion by CT or MRI (1.1 RECIST) Performance Status less than 2 according to ECOG Serum creatinine less than 1.5 mg/dL Hematological tests are as follows: Neutrophils more than 1500 cells per microliter, Platelets more than 100000 per microliter, Hemoglobin more than 9 g/dL The function of the liver is as follows: Direct bilirubin level less than 1.5 mg/dL, AST and ALT level less than 3 times ULN, Liver alkaline phosphatase less than 3 times ULN Albumin level greater than or equal to 3 g/dL Negative pregnancy blood test in women of childbearing age 28 days before starting the drug Consent to use a contraceptive method (both men and women (of reproductive age) who are sexually active must use contraceptive methods during treatment and for at least 6 months after treatment.) Sign the informed consent form
Exclusion criteria
Exclusion criteria: Patients with nasopharyngeal cancer or unknown origin Patients with HPV positive oropharynx (according to the pathology report) In locally advanced patients: previous systemic chemotherapy for the treatment of HNSCC and in metastatic or recurrent patients: previous systemic chemotherapy except in cases prescribed for the treatment of locally advanced disease and more than 3 months have passed since the last dose. Surgery or radiotherapy within 6 weeks before study entry Received prior anti-EGFR therapy less than 6 months prior to study entry History of hypersensitivity to cisplatin, carboplatin, docetaxel or cetuximab Brain or leptomeningeal metastasis NYHA IV-III heart failure, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the past 12 months Other malignancies within 1 years prior to randomization, excluding treated basal skin cancer and cervical carcinoma Active infections (requiring intravenous antibiotics), active TB infection, HIV, and hepatitis C and B A significant disease that, according to the researcher, does not make the patient a candidate for the study Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Control Rate (complete response (CR) or partial response (PR) or stable disease (SD) according to RECIST 1.1 criteria) at the end of chemotherapy. Timepoint: Week 12 in metastatic and recurrent patients, week 8 in locally advanced patients. Method of measurement: Imaging. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of Objective Response Rate (complete response (CR) or partial response (PR) based on RECIST 1.1 criteria) at the end of chemotherapy cycles in Abycet group compared to Erbitux. Timepoint: At the end of chemotherapy cycles. Method of measurement: Imaging.;Overall response rate (complete response (CR) or partial response (PR) assessed at the end of the second cycle of chemotherapy (6th week)). Timepoint: At the end of the second cycle of chemotherapy (sixth week). Method of measurement: Imaging.;Percentage of candidate patients receiving cetuximab maintenance dose (complete response (CR), partial response (PR) or stable disease (SD)). Timepoint: At the end of chemotherapy cycles. Method of measurement: Imaging.;Patient compliance to chemotherapy combined with cetuximab. Timepoint: At the end of chemotherapy cycles. Method of measurement: Checking the sequence and number of cetuximab doses and chemotherapy administered (insufficient compliance for cetuximab is defined as the patient missing more than 2 consecutive infusions of cetuximab, even if the missed infusions were due to adverse events. insufficient compliance for chemotherapy is defined as the patient missing more than 2 consecutive infusions of chemotherapy, even if the missed infusions were due to adverse events.).;Health-related quality of life. Timepoint: In the screening visit and the final week of the study (week 8 for locally advanced patients and week 12 for metastatic and recurrent patients). Method of measurement: Questionnaire (EORTC QLQ-C30, QLQ-H&N).;Safety outcome. Timepoint: For 12 weeks based on the reports and reviews done in weekly visits. Method of measurement: Safety will be evaluated based on side effect reports, laboratory test results, and vital signs measurements. Adverse events will be evaluated according to the National Cancer Institute CTC AE guidelines (v.5.0), which are grade 1 mild, moderate grade 2, severe grade 3, and life-threatening grade 4.;The result of immunogeni | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactZahra Rezagholi
Zistdaru Danesh Co.
Outcome results
None listed