Clinical Trials /

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

NCT04162873

Description:

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.

Related Conditions:
  • Head and Neck Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Celecoxib Through Surgery and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer
  • Official Title: RESILIENCE: Effect of Comprehensive Celecoxib Through Treatment for Advanced-Stage Head and Neck Cancer: A Randomized, Double-Blinded, Placebo-Controlled Trial

Clinical Trial IDs

  • ORG STUDY ID: HCI124211
  • SECONDARY ID: NCI-2019-07104
  • SECONDARY ID: HCI124211
  • SECONDARY ID: P30CA042014
  • NCT ID: NCT04162873

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

Interventions

DrugSynonymsArms
CelecoxibBenzenesulfonamide, 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]-, Celebrex, SC-58635, YM 177Celecoxib Arm

Purpose

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.

Detailed Description

      PRIMARY OBJECTIVE:

      I. To assess the number of days from surgery to initiation of radiation and adjuvant therapy
      with the addition of celecoxib compared to placebo.

      SECONDARY OBJECTIVES:

      I. To assess overall pain control and management for patients on celecoxib compared to
      placebo.

      II. To assess functional outcomes for patients on celecoxib compared to placebo.

      III. To assess the effect of celecoxib therapy on Quality of Life (QoL) compared to placebo.

      IV. To assess the average number of treatment days missed during adjuvant therapy for
      patients on celecoxib compared to placebo.

      OUTLINE: Patients are randomized to 1 of 2 arms.

      ARM I: Patients receive celecoxib orally (PO) or via feeding tube twice daily (BID) starting
      5 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.

      ARM II: Patients receive placebo PO or via feeding tube BID starting 5 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.
    

Trial Arms

NameTypeDescriptionInterventions
Celecoxib ArmExperimentalPatients receive celecoxib PO or via feeding tube BID starting 5 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.
  • Celecoxib
Placebo ArmPlacebo ComparatorPatients receive placebo PO or via feeding tube BID starting 5 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.

    Eligibility 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 celecoxib 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 separate readings 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
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:The number of days from surgery to the initiation of radiation and adjuvant therapy
    Time Frame:up to 6 months
    Safety Issue:
    Description:The day of surgery will be considered day 0 and the number of days will be counted until the first dose of adjuvant therapy. A Gaussian mixed effects regression model will be used to compare the average number of days from surgery to the initiation of radiation and adjuvant therapy between treatment and control groups. The model will contain fixed effects for treatment arm and provider and a nested random effect for patient within provider. The mean difference between treatment groups, two-sided p-value and 95% confidence interval will be calculated from the model.

    Secondary Outcome Measures

    Measure:Assessment of overall pain control and management for patients on celecoxib compared to placebo.
    Time Frame:Up to 3 years
    Safety Issue:
    Description:Assessment of subjective pain scores on the visual analog scale of pain intensity averaged over a week at rest, with a swallow, and with a cough. Pain intensity scale is a range from 0-10. 0= No Pain, 5= Moderate pain, 10= Unbearable paining
    Measure:Assessment of functional outcomes for patients on celecoxib compared to placebo
    Time Frame:Up to 3 years
    Safety Issue:
    Description:Assessment of current activity level and swallowing capabilities, including food and liquid variety and assessment of G tube utilization.
    Measure:To assess the effect of celecoxib therapy on Quality of Life (QoL) compared to placebo.
    Time Frame:Up to 3 years
    Safety Issue:
    Description:Completion of quality of life questionnaire EORTC QLQ-H&N43 as per the protocol described schedule.
    Measure:Assessment of the average number of treatment days missed during adjuvant therapy for patients on celecoxib compared to placebo.
    Time Frame:up to 3 years
    Safety Issue:
    Description:Assess the number of treatment days missed or delayed during adjuvant therapy.
    Measure:Assessment of overall pain control and management for patients on celecoxib compared to placebo.
    Time Frame:up to 3 years
    Safety Issue:
    Description:Narcotic consumption will be assessed in daily total morphine equivalents averaged over a week
    Measure:Assessment of overall pain control and management for patients on celecoxib compared to placebo.
    Time Frame:up to 3 years
    Safety Issue:
    Description:Patient satisfaction will be assessed with pain control questionnaire.
    Measure:To assess the effect of celecoxib therapy on Quality of Life (QoL) compared to placebo.
    Time Frame:up to 3 years
    Safety Issue:
    Description:Completion of quality of life questionnaire MDASI-HN as per the protocol described schedule.

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Not yet recruiting
    Lead Sponsor:University of Utah

    Last Updated