Celecoxib Through Surgery and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer

• Status: Recruiting
• Trial end date: 2025-10-12
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial studies how well celecoxib works through surgery and radiation therapy in treating patients with head and neck cancer that has spread to other places in the body (advanced). Celecoxib is Food and Drug Administration approved to treat arthritis, acute pain, and painful menstrual periods. Adding celecoxib to standard of care treatment may help to decrease the amount of time between surgery and radiation therapy.

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

Details

• Lead Sponsor: University of Utah
• Collaborator: National Cancer Institute (NCI)
• Treatments: Benzenesulfonamide; Celecoxib

Criteria

Inclusion Criteria:

• Advanced-stage (overall stage III and IV) head and neck cancers (sinonasal oral cavity, oropharynx, larynx, and hypopharynx) undergoing surgical resection and then adjuvant therapy. Primary and recurrence cases are acceptable

• Karnofsky performance status of >= 80

• Hemoglobin >= 10 g/dL

• Total bilirubin =< 2 mg/dL

• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal (ULN)

• Albumin > 3.5 g/dL

• Estimated glomerular filtration rate (eGFR) >= 30 mL/min/1.73 m^2 or creatinine clearance >= 30 mL/min by Cockcroft-Gault

• Serum potassium within normal limits

• Negative serum or urine pregnancy test at screening for women of childbearing potential

• Highly effective contraception for female subjects throughout the study and for at least 5 days after the last dose of study therapy if the risk of conception exists

• Recovery to baseline or =< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy

• Willing to maintain a diary of all opioids used during the trial for the treatment of pain

• Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines

Exclusion Criteria:

• Known metastatic disease or the tumor is deemed not surgically resectable

• Established in a pain management clinic or has taken opioids regularly >= 6 months

• Known or suspected to be poor CYP2C9 metabolizers based on previous history/experience with other CYP2C9 substrates (such as warfarin, phenytoin)

• Known hypersensitivity to celecoxib, aspirin, other non-steroidal anti-inflammatory drug (NSAID)s, or sulfonamides

• Uncontrolled hypertension defined as blood pressure (BP) > 150 mmHg systolic or > 90 mmHg diastolic on three consecutive reads, taken in one sitting despite optimal antihypertensive treatment

• Patients with a known history of the following:

• Cerebrovascular accident (CVA), stroke, or cardiovascular thrombotic events (e.g. acute myocardial infarction).

• Chronic heart failure.

• Gastrointestinal bleeding, ulceration, peptic ulcer disease, or perforation of the stomach or intestines.

• Aspirin-sensitive asthma.

• Chronic kidney disease, stage 4 or 5

• Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

• The subject has uncontrolled, significant intercurrent or recent illness requiring systemic therapy, would preclude safe study participation, or is deemed clinically significant by the investigator

• Known human immunodeficiency virus (HIV) infection with a detectable viral load within 6 months of the anticipated start of treatment.

• Note: Patients on effective anti-retroviral therapy with an undetectable viral load within 6 months of the anticipated start of treatment are eligible for this trial

• Known chronic hepatitis B virus (HBV) or hepatitis C virus infection with a detectable viral load.

• Note: Patients with an undetectable HBV viral load on appropriate suppressive therapy are eligible. Patients with an undetectable hepatitis C virus (HCV) viral load on appropriate treatment are eligible

• Subjects taking prohibited medications . A washout period of prohibited medications for a period of at least 5 half-lives or as clinically indicated should occur prior to the start of treatment