A Phase 2a Randomized, Parallel Group, Open Label, Multicenter Study to Assess the Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Locally Advanced Squamous Cell Carcinoma of the Oral Cavity or Oropharynx

Status: Completed
Location: See all (12) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2

The purpose of this study is to determine if RRx-001, which is added on to the cisplatin and radiation treatment, reduces the duration or length 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 in arms 1, 2 and 3 will also receive RRx-001 on different schedules.

Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No

• Pathologically confirmed diagnosis of squamous cell carcinoma (SCC) of the oral cavity and oropharynx Note: Patients with unknown primary tumors whose treatment plan matches the requirements specified in Inclusion Criterion #3 below are eligible for the trial

• Treatment planned to include standard cisplatin monotherapy administered either every three weeks (100 mg/m2 for 3 doses) with concomitant radiation delivered as a continuous course of IMRT with single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose between 60 Gy and 72 Gy. Planned radiation treatment fields must include at least two oral sites (buccal mucosa, floor of mouth, tongue, soft palate) 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.

• ECOG performance status ≤ 2.

• Participants must have adequate organ and marrow function as defined below:

• A. Absolute neutrophil count (ANC) >1,500 / mm3 B. Platelets > 100,000 / mm3 C. Hemoglobin ≥ 9.0 g/dL

• Adequate renal and liver function as indicated by:

• A. Serum creatinine acceptable for treatment with cisplatin per institutional guidelines) B. Total bilirubin ≤ 1.5 x upper-normal limit (ULN) C. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN D. Alkaline phosphatase ≤ 2.5 x ULN

• Human papilloma virus (HPV) status in tumor has been documented using tumor immunohistochemistry for HPV-p16 or other accepted test for patients with cancers of the oropharynx, base of tongue, or unknown primary.

• Age 18 years or older

• 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.

• Ability to understand and sign a written informed consent document.

• Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) 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

• 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.

United States
John Wayne Cancer Institute @ Providence St. John's Health Center
Santa Monica
Centura Health Research Center
Washington, D.c.
George Washington University
Florida Hospital
North Carolina
East Carolina University
New York
Montefiore Medical Center
University of Cincinnati Medical Center
Ohio State University
Thomas Jefferson University
Ballad Health
Johnson City
Vanderbilt-Ingram Cancer Center
UT Southwestern
Time Frame
Start Date: July 12, 2018
Completion Date: October 8, 2020
Target number of participants: 48
Experimental: RRx-001 Pre-Treatment plus SOC
Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC (four doses total). No additional RRx-001 will be given during the course of RT/cisplatin
Experimental: RRx-001 Pre-Treatment, 2 Concurrent Doses plus SOC
Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC. In addition, one dose of RRx-001 will be given on the last radiation day in each of weeks 2 and 5 during RT/cisplatin administration
Experimental: RRx-001 Pre-Treatment, 6 Concurrent Doses plus SOC
Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC. In addition, one dose of RRx-001 will be given on the last radiation day of each of the first 6 weeks during RT/cisplatin administration
Active Comparator: Standard of Care
No doses of RRx-001 will be administered. Patients assigned to this arm will receive only standard of care in the form of a 7-week course of fractionated radiation therapy concurrent with a high-dose cisplatin regimen (100 mg/m2 dose in each of RT weeks 1, 4, and 7).
Kyle T. Colvett, Brian C Muzyka, Matthew Biagioli, Marcelo Bonomi, David Sher, Santosh Kesari, Seth Reiner, Rafi Kabarriti, Sharad Goyal, Vinita Takiar, Voichita Bar-Ad, Kenneth Niermann
Collaborators: Prothex Pharma, Inc.
Leads: EpicentRx, Inc.

This content was sourced from clinicaltrials.gov

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