Trial Title:
RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer
NCT ID:
NCT05966194
Condition:
Oral Mucositis
Conditions: Official terms:
Mucositis
Stomatitis
Cisplatin
Conditions: Keywords:
Head and Neck Cancer
Neck cancer
Oral cancer
Mucositis
Squamous cell carcinoma (SCC)
HPV
Oropharynx
Oral cavity
IMRT
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
RRx-001
Description:
RRx-001 for injection (4 mg or 8 mg)
Arm group label:
RRx-001 Pre-Treatment (4mg RRx-001) + Chemoradiation Therapy (CRT)
Arm group label:
RRx-001 Pre-Treatment (8mg RRx-001) + Chemoradiation Therapy (CRT)
Intervention type:
Radiation
Intervention name:
Intensity Modulated Radiation Therapy (IMRT)
Description:
Intensity Modulated Radiation Therapy of up to 72 Gy
Arm group label:
Placebo Pre-Treatment + Chemoradiation Therapy (CRT)
Arm group label:
RRx-001 Pre-Treatment (4mg RRx-001) + Chemoradiation Therapy (CRT)
Arm group label:
RRx-001 Pre-Treatment (8mg RRx-001) + Chemoradiation Therapy (CRT)
Intervention type:
Drug
Intervention name:
Cisplatin for injection 100 mg/m2
Description:
Cisplatin for injection 100 mg/m2
Arm group label:
Placebo Pre-Treatment + Chemoradiation Therapy (CRT)
Arm group label:
RRx-001 Pre-Treatment (4mg RRx-001) + Chemoradiation Therapy (CRT)
Arm group label:
RRx-001 Pre-Treatment (8mg RRx-001) + Chemoradiation Therapy (CRT)
Summary:
The purpose of this study is to determine if RRx-001, which is added on to the cisplatin
and radiation treatment, reduces the incidence of severe oral mucositis in patients with
head and neck cancers. All patients in this study will receive 7 weeks of standard of
care radiation therapy given with the chemotherapy agent, cisplatin. Patients will
receive RRx-001 or placebo before start of standard of care treatment.
Detailed description:
The standard treatment for head and neck cancer currently includes a chemotherapy drug
called cisplatin that is given by intravenous (IV) infusion and radiation, which is
delivered from a machine that precisely targets the tumor. One common and unfortunate
side effect of treatment with cisplatin and radiation is oral mucositis, which refers to
irritation of the lining of the mouth. Oral mucositis is a serious problem 1) because the
open mouth sores from oral mucositis may lead to severe pain, nutritional problems and
dehydration from an inability to eat and drink, an increased risk of infection from
bacteria and fungus and delay or discontinuation of treatment and 2) because there is
only one approved therapy to treat or prevent it.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Pathologically confirmed diagnosis of squamous cell carcinoma (SCC) of the oral
cavity or oropharynx Note: Patients with primary cancers that are presumed to be of
oropharyngeal origin may be included if they meet radiation field dosing criteria as
specified in Inclusion Criterion #2 below. Unknown primaries which are HPV+ are
acceptable. HPV determination must be made for all patients.
2. Radiation Treatment planned to receive standard IMRT with daily fractions of 2.0 to
2.2 Gy for a total cumulative dose of 60-72 Gy in conjunction with definitive or
adjuvant chemotherapy. Planned radiation treatment fields must include at least two
oral sites (soft palate, floor of mouth, buccal mucosa, tongue) that are each
planned to receive a total of > 55 Gy. Patients who have had prior surgery are
eligible, provided they have fully recovered from surgery, and patients who may have
surgery in the future are eligible.
3. ECOG performance status ≤ 2.
4. Participants must have adequate organ and marrow function as defined below:
• Absolute neutrophil count (ANC) ≥ 1,500 / mm3 2. Platelets ≥ 75,000 / mm3 3.
Hemoglobin ≥ 9.0 g/dL
5. Adequate renal and liver function as indicated by:
• Serum creatinine acceptable for treatment with cisplatin per institutional
guidelines) 2. Total bilirubin ≤ 1.5 x upper-normal limit (ULN) 3. Aspartate
aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN 4. Alkaline
phosphatase ≤ 2.5 x ULN
6. Human papilloma virus (HPV) status in tumor must be documented using tumor
immunohistochemistry for HPV-p16 or other accepted test (such as such as in situ
hybridization) for patients with cancers of the oropharynx (Rooper et al, 2016,
Martens 2017). HPV status at baseline optional for oral cavity tumors.
7. Age 18 years or older
8. Patient must consent to the access, review, and analysis of previous medical and
cancer history, including imaging data, by the sponsor or a third party nominated by
the sponsor.
9. Ability and willingness to understand and sign a written informed consent document.
10. Women of childbearing potential and men with partners of child-bearing potential
must agree to use adequate contraception (hormonal or barrier method of birth
control) prior to study entry, for the duration of study participation, and for 90
days following completion of therapy.
Note: A woman of child-bearing potential is any female (regardless of sexual
orientation, having undergone a tubal ligation, or remaining celibate by choice) who
meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been postmenopausal for at least 12 consecutive months
11. Adequate visual access to permit examination of the following oral cavity sites:
lips, buccal mucosa, floor of mouth, ventral and lateral tongue, and soft palate.
Exclusion Criteria:
1. Prior radiotherapy to the head and neck region.
2. Prior induction chemotherapy.
3. Tumors of the lips, salivary gland, nasopharynx, hypopharynx, or larynx.
4. Patients with simultaneous primaries
5. Stage IV, M1 (distant metastasis)
6. Prior or current use of approved or investigational anticancer agent other than
those provided in this study.
7. Grade 3 or 4 dysphagia or odynophagia (National Cancer Institute Common Toxicity
Criteria, version 5.0) or inability to eat a normal (solid) diet
8. Requirement at baseline for parenteral or gastrointestinal tube-delivered nutrition
for any reason or prophylactic insertion of gastrostomy tube with dependency on tube
feeding at baseline.
9. Malignant tumors other than squamous cell carcinoma of the head and neck within last
5 years, unless treated definitively and with low risk of recurrence in the judgment
of the treating investigator.
10. Active infectious disease excluding oral candidiasis.
11. Presence of oral mucositis (WHO Score ≥ Grade 1) or other oral mucosal ulceration at
baseline.
12. Untreated active oral or dental infection
13. Known history of human immunodeficiency virus or active hepatitis B or C.
14. Any significant medical diseases or conditions, as assessed by the investigators and
sponsor that would substantially increase the medical risks of participating in this
study (i.e., uncontrolled diabetes, NYHA II-IV congestive heart failure, myocardial
infarction within 6 months of study, severe chronic pulmonary disease or active
uncontrolled infection, uncontrolled or clinically relevant pulmonary edema)
15. Pregnant or nursing.
16. Known allergies or intolerance to cisplatin or other platinum-containing compounds.
17. Sjogren syndrome
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Banner MD Anderson Cancer Center
Address:
City:
Gilbert
Zip:
85234
Country:
United States
Status:
Recruiting
Contact:
Last name:
Erin Nicoson
Phone:
480-256-5484
Email:
erin.nicoson@bannerhealth.com
Facility:
Name:
The University of Arizona Cancer Center
Address:
City:
Tucson
Zip:
85719
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alana Sudkamp
Phone:
520-694-4377
Email:
alanamsudkamp@arizona.edu
Facility:
Name:
Miami Cancer Institute
Address:
City:
Miami
Zip:
33176
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amy Starosciak
Phone:
786-596-2000
Email:
amyst@baptisthealth.net
Facility:
Name:
Northwestern University Feinberg School of Medicine
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Contact:
Phone:
312-695-0990
Email:
cancer@northwestern.edu
Facility:
Name:
Parkview Cancer Institute
Address:
City:
Fort Wayne
Zip:
46845
Country:
United States
Status:
Recruiting
Contact:
Last name:
Brian Chang, MD
Phone:
833-724-8326
Email:
brian.chang2@parkview.com
Facility:
Name:
Willis Knighton Cancer Center
Address:
City:
Shreveport
Zip:
71103
Country:
United States
Status:
Recruiting
Contact:
Last name:
Briana Barrow
Phone:
318-212-8671
Email:
bbarrow@wkhs.com
Facility:
Name:
Sandra and Malcolm Berman Cancer Institute
Address:
City:
Baltimore
Zip:
21204
Country:
United States
Status:
Recruiting
Contact:
Last name:
Laura Morse Cucci
Email:
lmorsecucci@gbmc.org
Facility:
Name:
University of Michigan
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Brandy Slusser
Email:
slusserb@med.umich.edu
Facility:
Name:
Renown Regional Medical Center
Address:
City:
Reno
Zip:
89502
Country:
United States
Status:
Recruiting
Contact:
Phone:
775-982-5050
Email:
renown-crd@renown.org
Facility:
Name:
East Carolina University School of Medicine
Address:
City:
Greenville
Zip:
27834
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kristin Wooten
Phone:
252-744-3617
Email:
wootenk16@ecu.edu
Facility:
Name:
The Ohio State University James Cancer Hospital & Solove Research Institute
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Harley Hamilton
Phone:
614-685-6493
Email:
Harley.Hamilton@osumc.edu
Facility:
Name:
Ballad Health
Address:
City:
Johnson City
Zip:
37604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Charles Mays, III, PhD
Phone:
423-431-5654
Email:
Charles.Mays@balladhealth.org
Facility:
Name:
University of Texas Southwestern Medical Center
Address:
City:
Dallas
Zip:
75390
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sarah Neufeld
Phone:
214-648-1836
Email:
Sarah.Hardee@UTSouthwestern.edu
Facility:
Name:
University of Virginia
Address:
City:
Charlottesville
Zip:
22908
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rachael Zhang
Phone:
434-982-1901
Email:
rlz4fp@uvahealth.org
Start date:
April 2, 2024
Completion date:
October 1, 2025
Lead sponsor:
Agency:
EpicentRx, Inc.
Agency class:
Industry
Source:
EpicentRx, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05966194
