Induction Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
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.
Head and Neck Cancer
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Carboplatin, Nab-paclitaxel and Cetuximab for Induction Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck|
- Clinical Response Rate Following Induction Chemotherapy [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]Evaluation of target lesions via imaging with CT or MRI scans at 2-3 weeks post induction chemotherapy.
- Rate of Complete Response following Induction Chemotherapy [ Time Frame: Baseline evaluation to 3 weeks after induction chemotherapy ] [ Designated as safety issue: No ]Report the rate of complete responses, defined as disappearance of all target lesions, following induction chemotherapy.
- Progression Free Survival and Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]Imaging of target lesions via CT or MRI scan post induction chemotherapy and chemoradiotherapy every 3 months for at least one year, and every 6 months for at least one year following completion of definitive chemoradiotherapy with or without surgery
- Toxicity evaluation [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.
- Quality of Life [ Time Frame: 2 years ] [ Designated as safety issue: No ]ECOG Performance status and FACT-HN will be completed at screening, 3 weeks post induction chemotherapy, 6 weeks post concomitant chemoradiotherapy, every 3 months in the first year, and every 6 months in the second year.
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||February 2018|
|Estimated Primary Completion Date:||February 2017 (Final data collection date for primary outcome measure)|
Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.
Other Name: ErbituxDrug: Nab-paclitaxel
Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.
Other Name: AbraxaneDrug: Carboplatin
Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks.
Other Name: Paraplatin
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 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 TPF regimen which includes docetaxel, cisplatin and 5-fluorouracil (5FU).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01412229
|Contact: Dale Flowers, RNemail@example.com|
|Contact: Donna Rowe, RNfirstname.lastname@example.org|
|United States, North Carolina|
|University of North Carolina at Chapel Hill||Recruiting|
|Chapel Hill, North Carolina, United States, 27599|
|Contact: Dale Flowers, RN 919-966-4432 email@example.com|
|Principal Investigator: Jared Weiss, MD|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator: Jill Gilbert, MD|
|United States, Washington|
|University of Washington||Recruiting|
|Seattle, Washington, United States, 98194|
|Principal Investigator: Renato Martins, MD, MPH|
|Principal Investigator:||Jared Weiss, MD||University of North Carolina, Chapel Hill|