Induction Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Completed · Phase 2

Conditions studied: Head and Neck Cancer

In brief

This is a non-randomized, open-label phase II trial of 40 patients with poor prognosis head and neck cancer, defined as surgically unresectable and/or ≥N2b disease and judged appropriate for non-surgical definitive therapy.

Key facts

Study ID: NCT01412229
Run by: UNC Lineberger Comprehensive Cancer Center
People needed: 40
Starts: 2012-02-01
Expected to finish: 2019-12-01
Last updated by the study team: 2020-11-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histologically or cytologically confirmed SCCHN or poorly differentiated or undifferentiated cancer of the head and neck.
Measurable disease.
All primary sites are eligible excluding nasopharyngeal.
Surgically unresectable and/or N2b or greater nodal disease; Note: surgical unresectability will be defined as the combination of the treating surgeon's judgment of unresectability plus one of the following objective criteria:
Encasement of tumor or nodes to the carotid artery or ¾ encasement of the carotid artery.
Involvement of prevertebral musculature
Invasion of the bone of the skull base
Need for glossectomy or extensive glossal resection where functional outcome is considered unacceptable to surgeon or patient
Involvement of the cervical spine
Severe, unacceptable functional deficit that would result from any proposed definitive surgical resection.
ECOG performance status 0-1
Prior therapy:
Chemotherapy: No prior chemotherapy for the treatment of SCCHN.
Platinum chemotherapy: No previous history of carboplatin or cisplatin therapy.
Nab-paclitaxel: No previous treatment with nab-paclitaxel or another taxane.
Cetuximab: No previous treatment with cetuximab Or another epidermal growth factor receptor (EGFR) inhibitor.
Radiation therapy: No prior radiation to the head and neck region.
Age > or = 18 years. Men and women are eligible for participation.
Must have acceptable organ and marrow function as defined below. Laboratory tests should be completed within 14 days prior to registration:
Absolute Neutrophil Count (ANC) > or = 1,500/mm3
Platelets > or = 100,000/mm3
Hemoglobin (Hgb) > 9g/dL
Total bilirubin < or = 1.5mg/dL
Albumin > 2.5 g/dL
Aspartate aminotransferase (AST)/Alanine Aminotransferase (ALT) < or = 2.5 times institutional upper limit of normal, alkaline phosphatase < 2.5 x upper limit of normal, glomerular filtration rate (GFR) > 30 mL/min (by standard Cockcroft and Gault formula or measured via 24 hour urine collection)

You may not qualify if…

Prior treatment with any of the study medications.
Prior radiation to any of the field required to treat the tumor.
Any metastatic disease.
The patient may have had a prior malignancy but must be disease-free for three years prior to study entry. A history of superficial non-melanoma skin cancer or in situ carcinoma of the cervix less than three years will be allowed.
Pregnant or lactating female
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring IV antibiotics, or psychiatric illness/social situations that would limit compliance with study requirements. Cardiac disease such as symptomatic congestive heart failure, unstable angina pectoris, or myocardial infarction will result in exclusion only if active within the past six months. Cardiac dysrhythmia will only result in exclusion if active and symptomatic (for example, rate-controlled atrial fibrillation will not result in exclusion).

Where it is running

University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
Vanderbilt University — Nashville, Tennessee, United States
University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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