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

Primary Purpose

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

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Celecoxib
Placebo
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 radiation. 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
  • 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

Sites / Locations

  • Huntsman Cancer Institute/University of UtahRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Celecoxib Arm

Placebo Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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. 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

Assessment of overall pain control and management for patients on celecoxib compared to placebo.
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
Assessment of functional outcomes for patients on celecoxib compared to placebo
Assessment of current activity level and swallowing capabilities, including food and liquid variety and assessment of G tube utilization.
To assess the effect of celecoxib therapy on Quality of Life (QoL) compared to placebo.
Completion of quality of life questionnaire EORTC QLQ-H&N43 as per the protocol described schedule.
Assessment of the average number of treatment days missed during adjuvant radiation for patients on celecoxib compared to placebo.
Assess the number of treatment days missed or delayed during adjuvant radiation.
Assessment of overall pain control and management for patients on celecoxib compared to placebo.
Narcotic consumption will be assessed in daily total morphine equivalents averaged over a week
Assessment of overall pain control and management for patients on celecoxib compared to placebo.
Patient satisfaction will be assessed with pain control questionnaire.
To assess the effect of celecoxib therapy on Quality of Life (QoL) compared to placebo.
Completion of quality of life questionnaire MDASI-HN as per the protocol described schedule.

Full Information

First Posted
November 4, 2019
Last Updated
June 23, 2023
Sponsor
University of Utah
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04162873
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 27, 2019 (Actual)
Primary Completion Date
October 12, 2024 (Anticipated)
Study Completion Date
October 12, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Utah
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
PRIMARY OBJECTIVE: I. To assess the number of days from surgery to initiation of radiation 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 radiation 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Celecoxib Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Other Intervention Name(s)
Benzenesulfonamide, 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]-, Celebrex, SC-58635, YM 177
Intervention Description
Given PO or via feeding tube
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
placebo therapy, PLCB, sham therapy
Intervention Description
Given PO or via feeding tube
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
The number of days from surgery to the initiation of radiation and adjuvant therapy
Description
The day of surgery will be considered day 0 and the number of days will be counted until the first dose of adjuvant radiation. 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.
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Assessment of overall pain control and management for patients on celecoxib compared to placebo.
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
Time Frame
Up to 3 years
Title
Assessment of functional outcomes for patients on celecoxib compared to placebo
Description
Assessment of current activity level and swallowing capabilities, including food and liquid variety and assessment of G tube utilization.
Time Frame
Up to 3 years
Title
To assess the effect of celecoxib therapy on Quality of Life (QoL) compared to placebo.
Description
Completion of quality of life questionnaire EORTC QLQ-H&N43 as per the protocol described schedule.
Time Frame
Up to 3 years
Title
Assessment of the average number of treatment days missed during adjuvant radiation for patients on celecoxib compared to placebo.
Description
Assess the number of treatment days missed or delayed during adjuvant radiation.
Time Frame
up to 3 years
Title
Assessment of overall pain control and management for patients on celecoxib compared to placebo.
Description
Narcotic consumption will be assessed in daily total morphine equivalents averaged over a week
Time Frame
up to 3 years
Title
Assessment of overall pain control and management for patients on celecoxib compared to placebo.
Description
Patient satisfaction will be assessed with pain control questionnaire.
Time Frame
up to 3 years
Title
To assess the effect of celecoxib therapy on Quality of Life (QoL) compared to placebo.
Description
Completion of quality of life questionnaire MDASI-HN as per the protocol described schedule.
Time Frame
up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 radiation. 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 Subject has verbally confirmed they are willing to complete adjuvant radiation therapy if recommended after surgery per protocol. Adjuvant radiation has been recommended by the institutional treatment planning conference with the best available data, but will be confirmed based on final surgical pathology. 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Morgan Schenk
Phone
801-585-0963
Email
morgan.schenk@hci.utah.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Cannon, MD
Organizational Affiliation
Huntsman Cancer Institute/ University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huntsman Cancer Institute/University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard B. Cannon
Phone
801-585-0255
Email
Richard.Cannon@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Richard B. Cannon

12. IPD Sharing Statement

Plan to Share IPD
No

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

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