MRX, Radiation, and Chemotherapy for Patients With Resected Squamous Cell Carcinoma of the Head and Neck
Rationale for Study
Oral mucositis is a major complication arising from contemporary chemoradiation treatment of patients with head and neck cancer.
No effective therapy exists to prevent this complication in this population. MRX-1024 is an investigational agent that has demonstrated in in vitro and in vivo experiments to have the potential to exert a protective effect in normal mucosa cells, without interfering with the intended antitumor effect of radiation.
A pilot Phase 1 study of MRX-1024 was conducted in India in patients with head and neck cancer receiving radiation alone or radiation in combination with cisplatin or carboplatin. MRX 1024 doses of 100 mgkg given orally twice a day, five days a week during radiation treatment cycles, were well tolerated and appeared to exert a protective effect against the development of severe mucositis.
Twice daily doses of MRX 1024 impose a certain level of inconvenience to the patient, to their clinic companion, and to the general work flow within radiation oncology clinics.
This study is designed to study the safety and pharmacokinetics of both single daily dose and twice daily dose regimens of oral MRX 1024 given in conjunction with daily radiation fractions and intermittent high-dose cisplatin to patients with high-risk for recurrence head and neck cancer following surgical resection. The study will also document the incidence and severity of oral mucositis that occurs following such therapy. The results will be instrumental in determining the regimen of MRX 1024 to use in subsequent definitive clinical trials.
Squamous Cell Carcinoma
Head and Neck Cancer
Resected Head and Neck Cancer
Drug: Oral MRX-1024
Procedure: Standard Fractionation Radiation Therapy
Drug: High-Dose Cisplatin Chemotherapy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1 Study of Oral MRX-1024 in Combination With Standard Fractionation Radiation Therapy and High-Dose Cisplatin in Patients With Squamous Cell Carcinoma of the Head and Neck Following Surgical Resection|
- safe recommended doses and dose regimen for oral MRX-1024 with concurrent chemoradiation.
- Identify toxicity profile of oral MRX-1024.
- Determine pharmacokinetic parameters of oral MRX-1024.
- Possibly show a trend in activity of MRX-1024 in preventing or reducing oral mucositis.
|Study Start Date:||January 2007|
|Study Completion Date:||July 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00427102
|Principal Investigator:||Gopal Bajaj, M.D.||Johns Hopkins University|