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

NCT02542215 | Terminated Phase 2 DMC

• 1 other identifier: SCMP-8811-202
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 76

Brief Summary

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.

Conditions

Oral Mucositis

Outcome Measures

Primary Outcomes (2)

• 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

  50 Gray (Gy), up to 12 weeks

• Overall mean Area Under the Curve (AUC) of oral mucositis severity over time

  50 Gray (Gy), up to 12 weeks

Secondary Outcomes (4)

• Time-to-onset of severe [World Health Organization (WHO) grade 3 or 4] oral mucositis following initiation of RT/CT

  50 Gray (Gy), up to 12 weeks

• Duration of severe (World Health Organization [WHO] grade 3 or 4) oral mucositis

  50 Gray (Gy), up to 12 weeks

• Weekly Quality of Life assessment [MD Anderson Symptom Inventory Head and Neck Cancer Module (MDASI-HN)]

  50 Gray (Gy), up to 12 weeks

• Mean cumulative radiation dose at time of severe (WHO grade 3 or 4) oral mucositis onset

  50 Gray (Gy), up to 12 weeks

Study Arms (2)

Cobiprostone 30 mcg four times daily

EXPERIMENTAL

Cobiprostone oral spray, four times daily, in addition to standard care radiation and chemotherapy

Drug: Cobiprostone; Drug: Standard Care - Chemotherapy; Radiation: Standard Care - Radiation

Placebo 0 mcg four times daily

PLACEBO COMPARATOR

Matching placebo oral spray, four times daily, in addition to standard care radiation and chemotherapy

Drug: Placebo; Drug: Standard Care - Chemotherapy; Radiation: Standard Care - Radiation

Interventions

Cobiprostone DRUG

Cobiprostone 30 mcg oral spray

Also known as: SPI-8811

Cobiprostone 30 mcg four times daily

Placebo DRUG

Matching placebo oral spray

Also known as: Placebo comparator

Placebo 0 mcg four times daily

Standard Care - Chemotherapy DRUG

Chemotherapy, as given with radiation as standard care for patients with head and neck cancer.

Also known as: Chemotherapy

Cobiprostone 30 mcg four times daily; Placebo 0 mcg four times daily

Standard Care - Radiation RADIATION

Radiation, as given with chemotherapy as standard care for patients with head and neck cancer.

Also known as: Radiation

Cobiprostone 30 mcg four times daily; Placebo 0 mcg four times daily

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sucampo Pharma Americas, LLC: lead

Study Sites (76)

Investigational Site

Birmingham, Alabama, 35294, United States

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Peoria, Arizona, 85381, United States

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Yuma, Arizona, 85364, United States

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Little Rock, Arkansas, 72205, United States

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Duarte, California, 91010, United States

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Fullerton, California, 92835, United States

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Los Angeles, California, 90048, United States

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Montebello, California, 90640, United States

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Oceanside, California, 92056, United States

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Redondo Beach, California, 90277, United States

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San Francisco, California, 94115, United States

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Whittier, California, 90603, United States

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Denver, Colorado, 80210, United States

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Farmington, Connecticut, 06030, United States

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Fort Lauderdale, Florida, 33316, United States

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Fort Myers, Florida, 33908, United States

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Lakeland, Florida, 33805, United States

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Miami Beach, Florida, 33140, United States

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Naples, Florida, 34102, United States

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Plantation, Florida, 33322, United States

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Stuart, Florida, 34994, United States

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Winter Haven, Florida, 33880, United States

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Boise, Idaho, 83706, United States

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Urbana, Illinois, 61801, United States

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Fort Wayne, Indiana, 46845, United States

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South Bend, Indiana, 46601, United States

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Topeka, Kansas, 66606, United States

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Ashland, Kentucky, 41101, United States

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Baton Rouge, Louisiana, 70809, United States

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Metairie, Louisiana, 70006, United States

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New Orleans, Louisiana, 70112, United States

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Shreveport, Louisiana, 71103, United States

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Baltimore, Maryland, 21201, United States

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Bethesda, Maryland, 20889, United States

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Burlington, Massachusetts, 01805, United States

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Ann Arbor, Michigan, 48109, United States

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Detroit, Michigan, 48201, United States

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East Lansing, Michigan, 48867, United States

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Minneapolis, Minnesota, 55417, United States

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St Louis, Missouri, 63110, United States

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Billings, Montana, 59101, United States

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Omaha, Nebraska, 68198, United States

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Reno, Nevada, 89502, United States

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Egg Harbor, New Jersey, 08234, United States

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New Brunswick, New Jersey, 08901, United States

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Charlotte, North Carolina, 28203, United States

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Gastonia, North Carolina, 28054, United States

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Greenville, North Carolina, 27834, United States

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Canton, Ohio, 44718, United States

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Sylvania, Ohio, 43560, United States

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Oklahoma City, Oklahoma, 73104, United States

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Coos Bay, Oregon, 97420, United States

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Corvallis, Oregon, 97330, United States

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Portland, Oregon, 97227, United States

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Gettysburg, Pennsylvania, 17325, United States

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Hershey, Pennsylvania, 17033, United States

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Natrona Heights, Pennsylvania, 15065, United States

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Philadelphia, Pennsylvania, 19104, United States

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Pittsburgh, Pennsylvania, 15232, United States

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State College, Pennsylvania, 16801, United States

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Pawtucket, Rhode Island, 02860, United States

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Myrtle Beach, South Carolina, 29577, United States

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Cookeville, Tennessee, 38501, United States

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Austin, Texas, 78701, United States

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Fort Sam Houston, Texas, 78234, United States

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Galveston, Texas, 77555, United States

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Houston, Texas, 77030, United States

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Houston, Texas, 77089, United States

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Temple, Texas, 76508, United States

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Charlottesville, Virginia, 22911, United States

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Fort Belvoir, Virginia, 22060, United States

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Bellingham, Washington, 98225, United States

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Everett, Washington, 98201, United States

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Seattle, Washington, 98101, United States

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Morgantown, West Virginia, 26506, United States

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Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Stomatitis

Interventions

cobiprostone; Drug Therapy; Radiation

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Phenomena

Study Officials

• Global Clinical Leader

  Mallinckrodt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2015
• First Posted: September 4, 2015
• Study Start: June 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: December 2, 2019

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (76)