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

NCT04162873 | Terminated Phase 2 Results DMC FDA Drug

• 3 other identifiers: HCI124211NCI-2019-07104P30CA042014
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Nasal Cavity and Paranasal Sinus Carcinoma; Oral Cavity Carcinoma; Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Pathologic Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Recurrent Hypopharyngeal Carcinoma; Recurrent Laryngeal Carcinoma; Recurrent Nasal Cavity and Paranasal Sinus Carcinoma; Recurrent Oral Cavity Carcinoma; Recurrent Oropharyngeal Carcinoma; Stage III Hypopharyngeal Carcinoma AJCC v8; Stage III Laryngeal Cancer AJCC v8; Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8; Stage IV Hypopharyngeal Carcinoma AJCC v8; Stage IV Laryngeal Cancer AJCC v8; Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8; Stage IVA Hypopharyngeal Carcinoma AJCC v8; Stage IVA Laryngeal Cancer AJCC v8; Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8; Stage IVB Hypopharyngeal Carcinoma AJCC v8; Stage IVB Laryngeal Cancer AJCC v8; Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8; Stage IVC Hypopharyngeal Carcinoma AJCC v8; Stage IVC Laryngeal Cancer AJCC v8; Stage IVC Oropharyngeal (p16-Negative) Carcinoma AJCC v8

Outcome Measures

Primary Outcomes (1)

• The Number of Days From Surgery to the Initiation of Radiation and Adjuvant Therapy

  The day of surgery will be considered day 0 and the number of days will be counted until the first dose of adjuvant radiation. This outcome measure will report the mean number of days from surgery to the initiation of radiation and adjuvant therapy for the Celecoxib and Placebo Arms.

  up to 3 months

Secondary Outcomes (9)

• Assessment of Overall Pain Control and Management for Patients on Celecoxib Compared to Placebo - Visual Analog Scale.

  Up to 29 days from the start of study treatment

• Assessment of Overall Pain Control and Management for Patients on Celecoxib Compared to Placebo - Pain Control Questionnaire.

  post-surgery (up to 29 days from surgery) and end of treatment (up to 5 months from surgery)

• Assessment of Overall Pain Control and Management for Patients on Celecoxib Compared to Placebo.

  Post-Surgery (1-7 days) up to 7 days, Post-Surgery (1-14 days) up to 14 days, Post-Surgery (1-26 days) up to 26 days, Post-Surgery (1-35 days) up to 35 days, and End of Treatment up to 146 days.

• Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo

  Post-Operation (up to 29 days after surgery), Mid Radiation (up to 112 days after surgery), and End of Treatment (up to 146 days after surgery)

• Assessment of Functional Outcomes for Patients on Celecoxib Compared to Placebo

  Post-Operation (up to 29 days after surgery), Mid Radiation (up to 112 days after surgery), and End of Treatment (up to 146 days after surgery)

Study Arms (2)

Celecoxib Arm

EXPERIMENTAL

Patients receive celecoxib PO or via feeding tube BID starting 1 to 7 days prior to surgery and continues until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity.

Drug: Celecoxib; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Placebo Arm

PLACEBO COMPARATOR

Patients receive placebo PO or via feeding tube BID starting 1 to 7 days prior to surgery and continues until the completion of radiation therapy (up to 6 months in total) in the absence of disease progression or unacceptable toxicity.

Other: Placebo; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Celecoxib DRUG

Given PO or via feeding tube

Also known as: Benzenesulfonamide, 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]-, Celebrex, SC-58635, YM 177

Celecoxib Arm

Placebo OTHER

Given PO or via feeding tube

Also known as: placebo therapy, PLCB, sham therapy

Placebo Arm

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Celecoxib Arm; Placebo Arm

Questionnaire Administration OTHER

Ancillary studies

Celecoxib Arm; Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 institutional guidelines
• Subject has verbally confirmed they are willing to complete adjuvant radiation therapy if recommended after surgery per protocol.

You may not qualify if:

• Known distant 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
• 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

Sponsors & Collaborators

• University of Utah: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Oropharyngeal Neoplasms; Paranasal Sinus Neoplasms; Mouth Neoplasms; Hypopharyngeal Neoplasms; Laryngeal Neoplasms; Carcinoma

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nose Neoplasms; Nose Diseases; Respiratory Tract Diseases; Paranasal Sinus Diseases; Respiratory Tract Neoplasms; Mouth Diseases; Laryngeal Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: IIT Data Management Team
• Organization: Research Compliance Office, Huntsman Cancer Institute

IITDataManagement@hci.utah.edu

801-213-6215

Study Officials

• Richard Cannon, MD

  Huntsman Cancer Institute/ University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 14, 2019
• Study Start: November 27, 2019
• Primary Completion: February 28, 2023
• Study Completion: April 26, 2023
• Last Updated: February 12, 2025
• Results First Posted: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)