Trials / Completed
CompletedNCT01412229
Induction Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
A Phase II Study of Carboplatin, Nab-paclitaxel and Cetuximab for Induction Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- UNC Lineberger Comprehensive Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cetuximab | Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy. |
| DRUG | Nab-paclitaxel | Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks. |
| DRUG | Carboplatin | Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks. |
Timeline
- Start date
- 2012-02-01
- Primary completion
- 2015-06-20
- Completion
- 2019-12-01
- First posted
- 2011-08-09
- Last updated
- 2020-11-23
- Results posted
- 2017-07-02
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01412229. Inclusion in this directory is not an endorsement.