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

Oral Mucositis Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02542215
• Other study ID #: SCMP-8811-202
• Status: Terminated
• Phase: Phase 2
• Start date: June 2015
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 47
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

Drug:
• Cobiprostone
Cobiprostone 30 mcg oral spray
• Placebo
Matching placebo oral spray
• Standard Care - Chemotherapy
Chemotherapy, as given with radiation as standard care for patients with head and neck cancer.

Radiation:
• Standard Care - Radiation
Radiation, as given with chemotherapy as standard care for patients with head and neck cancer.

Locations

Country	Name	City	State
United States	Investigational Site	Ann Arbor	Michigan
United States	Investigational Site	Ashland	Kentucky
United States	Investigational Site	Austin	Texas
United States	Investigational Site	Baltimore	Maryland
United States	Investigational Site	Baton Rouge	Louisiana
United States	Investigational Site	Bellingham	Washington
United States	Investigational Site	Bethesda	Maryland
United States	Investigational Site	Billings	Montana
United States	Investigational Site	Birmingham	Alabama
United States	Investigational Site	Boise	Idaho
United States	Investigational Site	Burlington	Massachusetts
United States	Investigational Site	Canton	Ohio
United States	Investigational Site	Charlotte	North Carolina
United States	Investigational Site	Charlottesville	Virginia
United States	Investigational Site	Cookeville	Tennessee
United States	Investigational Site	Coos Bay	Oregon
United States	Investigational Site	Corvallis	Oregon
United States	Investigational Site	Denver	Colorado
United States	Investigational Site	Detroit	Michigan
United States	Investigational Site	Duarte	California
United States	Investigational Site	East Lansing	Michigan
United States	Investigational Site	Egg Harbor Township	New Jersey
United States	Investigational Site	Everett	Washington
United States	Investigational Site	Farmington	Connecticut
United States	Investigational Site	Fort Belvoir	Virginia
United States	Investigational Site	Fort Lauderdale	Florida
United States	Investigational Site	Fort Myers	Florida
United States	Investigational Site	Fort Sam Houston	Texas
United States	Investigational Site	Fort Wayne	Indiana
United States	Investigational Site	Fullerton	California
United States	Investigational Site	Galveston	Texas
United States	Investigational Site	Gastonia	North Carolina
United States	Investigational Site	Gettysburg	Pennsylvania
United States	Investigational Site	Greenville	North Carolina
United States	Investigational Site	Hershey	Pennsylvania
United States	Investigational Site	Houston	Texas
United States	Investigational Site	Houston	Texas
United States	Investigational Site	Lakeland	Florida
United States	Investigational Site	Little Rock	Arkansas
United States	Investigational Site	Los Angeles	California
United States	Investigational Site	Madison	Wisconsin
United States	Investigational Site	Metairie	Louisiana
United States	Investigational Site	Miami Beach	Florida
United States	Investigational Site	Minneapolis	Minnesota
United States	Investigational Site	Montebello	California
United States	Investigational Site	Morgantown	West Virginia
United States	Investigational Site	Myrtle Beach	South Carolina
United States	Investigational Site	Naples	Florida
United States	Investigational Site	Natrona Heights	Pennsylvania
United States	Investigational Site	New Brunswick	New Jersey
United States	Investigational Site	New Orleans	Louisiana
United States	Investigational Site	Oceanside	California
United States	Investigational Site	Oklahoma City	Oklahoma
United States	Investigational Site	Omaha	Nebraska
United States	Investigational Site	Pawtucket	Rhode Island
United States	Investigational Site	Peoria	Arizona
United States	Investigational Site	Philadelphia	Pennsylvania
United States	Investigational Site	Pittsburgh	Pennsylvania
United States	Investigational Site	Plantation	Florida
United States	Investigational Site	Portland	Oregon
United States	Investigational Site	Redondo Beach	California
United States	Investigational Site	Reno	Nevada
United States	Investigational Site	Saint Louis	Missouri
United States	Investigational Site	San Francisco	California
United States	Investigational Site	Seattle	Washington
United States	Investigational Site	Shreveport	Louisiana
United States	Investigational Site	South Bend	Indiana
United States	Investigational Site	State College	Pennsylvania
United States	Investigational Site	Stuart	Florida
United States	Investigational Site	Sylvania	Ohio
United States	Investigational Site	Temple	Texas
United States	Investigational Site	Topeka	Kansas
United States	Investigational Site	Urbana	Illinois
United States	Investigational Site	Whittier	California
United States	Investigational Site	Winter Haven	Florida
United States	Investigational Site	Yuma	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Sucampo Pharma Americas, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Overall mean Area Under the Curve (AUC) of oral mucositis severity over time		50 Gray (Gy), up to 12 weeks
Secondary	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
Secondary	Duration of severe (World Health Organization [WHO] grade 3 or 4) oral mucositis		50 Gray (Gy), up to 12 weeks
Secondary	Weekly Quality of Life assessment [MD Anderson Symptom Inventory Head and Neck Cancer Module (MDASI-HN)]		50 Gray (Gy), up to 12 weeks
Secondary	Mean cumulative radiation dose at time of severe (WHO grade 3 or 4) oral mucositis onset		50 Gray (Gy), up to 12 weeks