Study of Nimotuzumab and Cisplatin/Radiotherapy for Locally Advanced Head and Neck Squamous Cell Cancer

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to define the response and toxicities with the addition of Nimotuzumab to chemoradiation for head and neck cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Centre, Singapore
• Collaborator: Innogene Kalbiotech Pte. Ltd
• Treatments: Cisplatin; Nimotuzumab

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed Squamous Cell Carcinoma of the Head and Neck.

• Locally advanced disease, unresectable disease or resectable disease where organ-preservation is intended

• Age > 18 years

• Adequate performance status of ECOG 0-2

• Life expectancy of at least 3 months

• Written informed consent to participate in the study

• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan.

• Patients must have normal organ and marrow function as defined below:

• leukocytes >3,000/uL

• absolute neutrophil count >1,500/uL

• platelets >100,000/uL

• total bilirubin within normal institutional limits

• AST(SGOT)/ALT(SGPT) < 2.5X normal . Creatinine within normal range and CCT(Cockcroft-Gault) > 50 ml/min

Exclusion Criteria:

• Prior treatment with anti-EGFR or chemotherapy/radiotherapy

• Evidence of CNS metastases

• Poor performance status (ECOG 3-4)

• Evidence of severe or uncontrolled systemic disease (eg. unstable or uncompensated respiratory disorder, cardiac failure, hepatic decompensation, renal failure, nephritic syndrome, uncontrolled metabolic disorders such as diabetes mellitus, uncontrolled hypertension or uncontrolled significant infections)

• Pregnancy or breast-feeding (women of child-bearing potential)

• Prior severe allergic drug reactions

• Prior history of cancer in the last 5 years prior to enrollment, other than curatively treated cancer of the cervix or non-melanoma skin cancer.