Phase I Study of CUDC-101 With Cisplatin and Radiation in Subjects With Head & Neck Cancer
Trial ID or NCT#
Status
NOT RECRUITING
Purpose
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.
Official Title
A Phase I Dose Escalation Study to Investigate the Safety and Pharmacokinetics of Intravenous CUDC-101 With Concurrent Cisplatin and Radiation Therapy in Subjects With Locally Advanced Head and Neck Cancer
Eligibility Criteria
- - Subjects with locally advanced, pathologically confirmed diagnosis of squamous cell carcinoma of the head and neck at the following sites: oral cavity, oropharynx, hypopharynx and larynx with either: - Stage IV p16 positive tumors and >10 pack-years smoking history. - Stage III/IV p16 negative tumors, regardless of smoking history. - At least evaluable disease; 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. - Subjects enrolled in the MTD expansion cohort must have at least 1 tumor lesion that is suitable for repeat biopsy (pre- and post-CUDC-101 infusion). - 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); total bilirubin ≤ 1.5x ULN; AST/ALT ≤ 2 x ULN. - Serum magnesium and potassium within normal limits (may be supplemented to achieve normal values) - Able to render informed consent and to follow protocol requirements.
- - 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 prior to study treatment. - 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 within 6 months prior to study treatment. - Known history of stroke or cerebrovascular accident within 6 months prior to study treatment. - Symptomatic cardiac conduction abnormality within 12 months prior to study treatment. - 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. - Central nervous system metastases.
Investigator(s)
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Contact
Cancer Clinical Trials Office
650-498-7061
View on ClinicalTrials.gov
