Phase I Study of CUDC-101 With Cisplatin and Radiation in Subjects With Human Papillomavirus Negative Head and Neck Cancer

Status: Recruiting
Phase: Phase 1
Diagnosis: Head and Neck Cancer
NCT ID: NCT01384799 (View complete trial on
DFCI Protocol ID: 11-103


This is a phase I dose escalation study of CUDC-101 in combination with concurrent cisplatin and radiation therapy in patients with locally advanced head and neck cancer. CUDC-101 is a multi-targeted agent designed to inhibit epidermal growth factor receptor (EGFR), human epidermal growth factor receptor Type 2 (Her2) and histone deacetylase (HDAC). The study is designed to establish the safety, tolerability and maximum tolerated dose (MTD) of CUDC-101 when administered in combination with concurrent cisplatin and radiation over an 8-week treatment course, consisting of a one week run-in period of CUDC-101 administered alone, followed by seven weeks of combination treatment with CUDC-101, cisplatin and radiation therapy.


Conducting Institutions:
Massachusetts General Hospital

Overall PI:
Lori Wirth, MD, Massachusetts General Hospital

Site-responsible Investigators:

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Subjects with stage III/IV, locally advanced, pathologically confirmed diagnosis of human papillomavirus negative squamous cell carcinoma of the head and neck. - At least evaluable disease and one measurable site of disease according to RECIST (Version 1.1) criteria (at least 10 mm for conventional CT/MRI or spiral CT scan) is desirable. - Age ≥ 18 years - ECOG performance < 2 - Life expectancy ≥ 3 months - If female, neither pregnant nor lactating - If of child bearing potential, must use adequate birth control throughout the participation in the treatment phase and for 60 days following the last study treatment. - Absolute neutrophil count ≥ 1,800/µL; platelets ≥ 100,000/µL; hemoglobin ≥ 8.0 g/dL, creatinine ≤ 1.5x upper limit of normal (ULN) or calculated creatinine clearance ≥ 60mL/min; total bilirubin ≤ 1.5x ULN; AST/ALT ≤ 2 x ULN ; prothrombin time and INR ≤1.5x ULN, unless receiving therapeutic anticoagulation - Serum magnesium and potassium within normal limits (may be supplemented to achieve normal values) - Able to render informed consent and to follow protocol requirements. Exclusion Criteria: - Prior radiotherapy to the region of the study cancer or adjacent anatomical sites, or > 25% of marrow-bearing area. - Prior chemotherapy for the current indication. - Prior therapy that specifically and directly targets EGFR, HER2 or HDAC. - Use of investigational agent(s) within 30 days of study entry - Primary tumor site of nasopharynx, sinuses, or salivary gland. - History of cardiac disease with a New York Heart Association (NYHA) Class II or greater congestive heart failure (CHF), myocardial infarction (MI) or unstable angina in the past 6 months prior to Day 1 of treatment, serious arrhythmias requiring medication for treatment. - Patients with prolonged QTc Interval >450 msec. - Acquired Immune Deficiency Syndrome (AIDS) or known infection with human immunodeficiency virus (HIV). Testing is not required. - Known history of gastrointestinal bleeding, ulceration, or perforation - Known history of stroke or cerebrovascular accident in the past 6 months prior to Day 1 of treatment. - Symptomatic conduction abnormality within the past 12 months. - Prior history of hearing impairment. - Known history of renal disease or ongoing renal impairment - Any uncontrolled condition (such as active systemic infection, diabetes, hypertension), which in the opinion of the investigator, could affect the subjects participation in the study. - Prior allergic reaction to cisplatin, carboplatin or other platinum-containing compounds. - Symptomatic central nervous system metastases.
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