At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed squamous cell carcinoma of oropharynx, hypopharynx, or larynx
- ✓Stage III or IV disease (T2, N2-3, M0 or T3-4, any N, M0)
- ✓ECOG performance status 0-1
- ✓No distant metastasis by imaging within past 6 weeks
- ✕Primary tumor of oral cavity, nasopharynx, sinuses, or salivary glands
- ✕Prior systemic chemotherapy for this cancer
- ✕Prior radiotherapy to the region of this cancer that would result in overlap of radiotherapy fields
- ✕Prior initial surgical treatment (excluding diagnostic biopsy)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II Study of Nab-paclitaxel, Cisplatin and Cetuximab With Concurrent Radiation Therapy for Local-regionally Advanced Head-and-neck Squamous Cell Carcinoma
In Brief
A Phase 2 clinical trial evaluating Cetuximab, Cisplatin, and 2 other interventions for Head and Neck Cancer. Completed, enrolled 37 participants across 2 sites.
Detailed Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Paclitaxel albumin-stabilized nanoparticle formulation may make tumor cells more sensitive to radiation therapy. Giving radiation therapy and paclitaxel albumin-stabilized nanoparticle formulation together with cisplatin and cetuximab may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with cisplatin, cetuximab, and radiation therapy to see how well they work in treating patients with locally advanced stage III or stage IV head and neck cancer.
Study Details
Timeline
Interventions
Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor
Cisplatin is an anti-cancer chemotherapy drug
paclitaxel albumin-stabilized nanoparticle formulation
intensity-modulated radiation therapy