Cobiprostone for the Prevention of Oral Mucositis in Subjects With Head and Neck Cancer Receiving Concurrent Radiation and Chemotherapy

November 26, 2019 updated by: Sucampo Pharma Americas, LLC

A Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy, Safety, and Pharmacokinetics of Cobiprostone for the Prevention of Severe Oral Mucositis in Subjects With Head and Neck Cancer (HNC)

Treatment for head and neck cancer often involves a combination of chemotherapy and radiation.

One of the unfortunate consequences of standard care for head and neck cancer is the development of painful mouth sores, known as oral mucositis.

This study will evaluate the use of cobiprostone spray to prevent oral mucositis, when given for the duration of radiation and chemotherapy (RT/CT) standard care.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Investigational Site
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Investigational Site
      • Yuma, Arizona, United States, 85364
        • Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Investigational Site
    • California
      • Duarte, California, United States, 91010
        • Investigational Site
      • Fullerton, California, United States, 92835
        • Investigational Site
      • Los Angeles, California, United States, 90048
        • Investigational Site
      • Montebello, California, United States, 90640
        • Investigational Site
      • Oceanside, California, United States, 92056
        • Investigational Site
      • Redondo Beach, California, United States, 90277
        • Investigational Site
      • San Francisco, California, United States, 94115
        • Investigational Site
      • Whittier, California, United States, 90603
        • Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80210
        • Investigational Site
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • Investigational Site
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Investigational Site
      • Fort Myers, Florida, United States, 33908
        • Investigational Site
      • Lakeland, Florida, United States, 33805
        • Investigational Site
      • Miami Beach, Florida, United States, 33140
        • Investigational Site
      • Naples, Florida, United States, 34102
        • Investigational Site
      • Plantation, Florida, United States, 33322
        • Investigational Site
      • Stuart, Florida, United States, 34994
        • Investigational Site
      • Winter Haven, Florida, United States, 33880
        • Investigational Site
    • Idaho
      • Boise, Idaho, United States, 83706
        • Investigational Site
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Investigational Site
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Investigational Site
      • South Bend, Indiana, United States, 46601
        • Investigational Site
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Investigational Site
    • Kentucky
      • Ashland, Kentucky, United States, 41101
        • Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Investigational Site
      • Metairie, Louisiana, United States, 70006
        • Investigational Site
      • New Orleans, Louisiana, United States, 70112
        • Investigational Site
      • Shreveport, Louisiana, United States, 71103
        • Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Investigational Site
      • Bethesda, Maryland, United States, 20889
        • Investigational Site
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Investigational Site
      • Detroit, Michigan, United States, 48201
        • Investigational Site
      • East Lansing, Michigan, United States, 48867
        • Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Investigational Site
    • Montana
      • Billings, Montana, United States, 59101
        • Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Investigational Site
    • Nevada
      • Reno, Nevada, United States, 89502
        • Investigational Site
    • New Jersey
      • Egg Harbor Township, New Jersey, United States, 08234
        • Investigational Site
      • New Brunswick, New Jersey, United States, 08901
        • Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Investigational Site
      • Gastonia, North Carolina, United States, 28054
        • Investigational Site
      • Greenville, North Carolina, United States, 27834
        • Investigational Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • Investigational Site
      • Sylvania, Ohio, United States, 43560
        • Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Investigational Site
    • Oregon
      • Coos Bay, Oregon, United States, 97420
        • Investigational Site
      • Corvallis, Oregon, United States, 97330
        • Investigational Site
      • Portland, Oregon, United States, 97227
        • Investigational Site
    • Pennsylvania
      • Gettysburg, Pennsylvania, United States, 17325
        • Investigational Site
      • Hershey, Pennsylvania, United States, 17033
        • Investigational Site
      • Natrona Heights, Pennsylvania, United States, 15065
        • Investigational Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15232
        • Investigational Site
      • State College, Pennsylvania, United States, 16801
        • Investigational Site
    • Rhode Island
      • Pawtucket, Rhode Island, United States, 02860
        • Investigational Site
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29577
        • Investigational Site
    • Tennessee
      • Cookeville, Tennessee, United States, 38501
        • Investigational Site
    • Texas
      • Austin, Texas, United States, 78701
        • Investigational Site
      • Fort Sam Houston, Texas, United States, 78234
        • Investigational Site
      • Galveston, Texas, United States, 77555
        • Investigational Site
      • Houston, Texas, United States, 77030
        • Investigational Site
      • Houston, Texas, United States, 77089
        • Investigational Site
      • Temple, Texas, United States, 76508
        • Investigational Site
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Investigational Site
      • Fort Belvoir, Virginia, United States, 22060
        • Investigational Site
    • Washington
      • Bellingham, Washington, United States, 98225
        • Investigational Site
      • Everett, Washington, United States, 98201
        • Investigational Site
      • Seattle, Washington, United States, 98101
        • Investigational Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Investigational Site

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Recently-diagnosed (within the last 6 months), histologically-documented, non-metastatic squamous cell carcinoma of the oral cavity and/or oropharynx amenable to radiotherapy with concurrent chemotherapy as the definitive treatment modality.
  • Clinical treatment plan calls for a minimum of 50 Gy cumulative radiation dose administered via continuous course of external beam irradiation to the oral cavity and/or oropharynx via intensity-modulated radiation therapy (IMRT) and/or image-guided radiation therapy (IGRT), combined with conventional or weekly/tri-weekly cisplatin or carboplatin chemotherapy regimen.

Exclusion Criteria:

  • Subject has received prior radiation to the head and neck region (+/- chemotherapy).
  • Subject has had any other prior invasive malignancy, unless disease-free for a minimum of 3 years.
  • Subject has metastatic disease (M1) Stage IV-C.
  • Subject has a presence of mucosal ulceration or oral mucositis at screening or develops this prior to randomization, and/or has unhealed wounds remaining from surgical resection and/or excisional biopsy procedure.
  • Subject is using a pre-existing feeding tube for nutritional support at study entry.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cobiprostone 30 mcg four times daily
Cobiprostone oral spray, four times daily, in addition to standard care radiation and chemotherapy
Drug: Cobiprostone
Cobiprostone 30 mcg oral spray
Other Names:
  • SPI-8811
Drug: Standard Care - Chemotherapy
Chemotherapy, as given with radiation as standard care for patients with head and neck cancer.
Other Names:
  • Chemotherapy
Radiation: Standard Care - Radiation
Radiation, as given with chemotherapy as standard care for patients with head and neck cancer.
Other Names:
  • Radiation
Placebo Comparator: Placebo 0 mcg four times daily
Matching placebo oral spray, four times daily, in addition to standard care radiation and chemotherapy
Drug: Standard Care - Chemotherapy
Chemotherapy, as given with radiation as standard care for patients with head and neck cancer.
Other Names:
  • Chemotherapy
Radiation: Standard Care - Radiation
Radiation, as given with chemotherapy as standard care for patients with head and neck cancer.
Other Names:
  • Radiation
Drug: Placebo
Matching placebo oral spray
Other Names:
  • Placebo comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects with a diagnosis of severe oral mucositis during the course of receiving up to 50 Gray (Gy) cumulative radiation dose administration with concurrent chemotherapy
Time Frame: 50 Gray (Gy), up to 12 weeks
50 Gray (Gy), up to 12 weeks
Overall mean Area Under the Curve (AUC) of oral mucositis severity over time
Time Frame: 50 Gray (Gy), up to 12 weeks
50 Gray (Gy), up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Time-to-onset of severe [World Health Organization (WHO) grade 3 or 4] oral mucositis following initiation of RT/CT
Time Frame: 50 Gray (Gy), up to 12 weeks
50 Gray (Gy), up to 12 weeks
Duration of severe (World Health Organization [WHO] grade 3 or 4) oral mucositis
Time Frame: 50 Gray (Gy), up to 12 weeks
50 Gray (Gy), up to 12 weeks
Weekly Quality of Life assessment [MD Anderson Symptom Inventory Head and Neck Cancer Module (MDASI-HN)]
Time Frame: 50 Gray (Gy), up to 12 weeks
50 Gray (Gy), up to 12 weeks
Mean cumulative radiation dose at time of severe (WHO grade 3 or 4) oral mucositis onset
Time Frame: 50 Gray (Gy), up to 12 weeks
50 Gray (Gy), up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sucampo Pharma Americas, LLC

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 Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

August 13, 2015

First Submitted That Met QC Criteria

September 3, 2015

First Posted (Estimate)

September 4, 2015

Study Record Updates

Last Update Posted (Actual)

December 2, 2019

Last Update Submitted That Met QC Criteria

November 26, 2019

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCMP-8811-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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