RECRUITING

First Line Weekly Chemo/Immunotherapy for Metastatic Head/Neck Squamous Cell Carcinoma Patients

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Conditions

Head Neck CancerMetastatic Squamous Cell CarcinomaOral Cavity Squamous Cell CarcinomaOropharynx Squamous Cell CarcinomaHypopharynx Squamous Cell CarcinomaLarynx Squamous Cell Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this research is to see what effects the treatment regimen chemotherapy (carboplatin and paclitaxel) plus immunotherapy (pembrolizumab), has on patients who have been diagnosed with head/neck squamous cell carcinoma and are unable to take the drug 5-fluorouracil

Official Title

Phase II Study of First Line Weekly Chemo/Immunotherapy for Metastatic Head/Neck Squamous Cell Carcinoma Patients

Quick Facts

Study Start:2021-05-27
Study Completion:2027-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04858269

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Recurrent or metastatic squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, larynx or neck node with occult primary but suspected to be non-cutaneous head/neck that is incurable by local therapies (i.e. radiation or surgery) and either locoregionally advanced or with at least one distant metastasis.
  2. * Histologic or cytologic confirmation of malignancy by pathology report.
  3. * Not a candidate for infusional 5FU (mucositis, 5-day infusional pump not feasible, patient refusal, other).
  4. * 18 years old or greater.
  5. * ECOG performance status of 0-2.
  6. * Life expectancy of greater than 3 months.
  7. * Patients must have normal organ and marrow function as defined: Absolute neutrophil count greater than or equal to 1,000/mcL, platelets greater than or equal to 75,000/mcL, total bilirubin less than or equal to 2 mg/dL
  8. * Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).
  1. * No prior systemic cancer-directed therapy administered in the recurrent or metastatic setting. Prior treatments are allowed if they were administered with curative intent prior to incurable progression of disease. Prior treatments for other cancers are also allowed.
  2. * Untreated, symptomatic central nervous system (CNS) metastases.
  3. * Active autoimmune disease requiring systemic immunosuppression.
  4. * History of autoimmune pneumonitis requiring high-dose systemic steroids (equivalent prednisone \>20 mg/day for \>1 week).
  5. * History of greater than or equal to Grade 3 hypersensitivity reaction to carboplatin or paclitaxel.
  6. * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  7. * Pregnant women are excluded from this study because paclitaxel and carboplatin are Class D agents with significant potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these drugs, breastfeeding should be discontinued during the study.

Contacts and Locations

Study Contact

Study Nurse
CONTACT
336-713-5440
saverill@wakehealth.edu
Jeffrey Kettler
CONTACT
336-713-5440
jkettler@wakehealth.edu

Principal Investigator

Thomas Lycan, DO
PRINCIPAL_INVESTIGATOR
Wake Forest Baptist Health Sciences

Study Locations (Sites)

Wake Forest Baptist Health Sciences
Winston-Salem, North Carolina, 27157
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • Thomas Lycan, DO, PRINCIPAL_INVESTIGATOR, Wake Forest Baptist Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-27
Study Completion Date2027-08

Study Record Updates

Study Start Date2021-05-27
Study Completion Date2027-08

Terms related to this study

Additional Relevant MeSH Terms

  • Head Neck Cancer
  • Metastatic Squamous Cell Carcinoma
  • Oral Cavity Squamous Cell Carcinoma
  • Oropharynx Squamous Cell Carcinoma
  • Hypopharynx Squamous Cell Carcinoma
  • Larynx Squamous Cell Carcinoma