Celecoxib Through Surgery and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer (NCT04162873) | Clinical Trial Compass
TerminatedPhase 2
Celecoxib Through Surgery and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer
Stopped: Insufficient funding
United States13 participantsStarted 2019-11-27
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female subject aged ≥ 18 years.
* Advanced-stage (overall stage III and IV) head and neck cancers (sinonasal oral cavity, oropharynx, larynx, and hypopharynx) undergoing surgical resection and then adjuvant radiation. Primary and recurrence cases are acceptable
* Karnofsky performance status of \>= 70
* 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 instituti…
What they're measuring
1
The Number of Days From Surgery to the Initiation of Radiation and Adjuvant Therapy