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.
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. Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 with good organ function and will be treated with six weekly cycles of carboplatin, nab-paclitaxel and cetuximab prior to scheduled concomitant chemoradiation. The study is designed to evaluate whether this induction regimen can result in an improved response rate (complete response (CR) + partial response (PR)) with less toxicity than the current standard induction docetaxel, cisplatin and 5-fluorouracil (TPF) regimen.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.
Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.
Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks.
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
Clinical Response Rate Following Induction Chemotherapy
Evaluation of target lesions via imaging with CT or MRI scans at 2-3 weeks post induction chemotherapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.
Time frame: 9 weeks
Rate of Complete Response Following Induction Chemotherapy
Report the rate of complete responses, defined as disappearance of all target lesions, following induction chemotherapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions.
Time frame: Baseline evaluation to 3 weeks after induction chemotherapy
Progression Free Survival
Rate of Progression Free Survival (Time to death or progression defined by imaging of target lesions via CT or MRI scan post induction chemotherapy and chemoradiotherapy every 3 months for one year)
Time frame: 1 year
Objective Response Rate (CR+PR)
Objective Response Rate as defined by RECIST 1.1 after induction chemotherapy followed by definitive chemoradiation. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.
Time frame: 20 weeks
Complete Response Rate (CR)
Complete Response Rate as defined by RECIST 1.1 after induction chemotherapy followed by definitive chemoradiation
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Time frame: 20 weeks
Overall Survival
Rate of Overall Survival
Time frame: 1 year
Number of Participants With at Least One Grade 3-4 Toxicity
Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.
Time frame: 9 Weeks
Number of Participants With at Least One Grade 3-4 Toxicity, Listed by Event
Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.
Time frame: 24 Weeks
Patient-reported Quality of Life Scores
Functional Assessment of Cancer Therapy - Head \& Neck (FACT-HN) is the FACT-G and a 12 item head and neck cancer specific subscale completed at screening (Screening), 3 weeks post induction chemotherapy (Treatment Break), 7 weeks post concomitant chemoradiotherapy (7 weeks Off Treatment), one year post off-treatment (1 year Off Treatment). The FACT-G is a 27 item measure of general QOL assessing function in 4 domains: physical well-being (PWB), social-family well-being (SFWB), emotional well-being (EWB) and functional well-being (FWB). Items are rated by patients on a Likert scale from 0 to 4 (resulting in potential total scores between 0 and 156). Higher scores represent better QOL.
Time frame: screening until one year after treatment