At a glance
ClinicalIndex Comparison Record- ✓Stage III-IVB head and neck cancer (all sites), including unknown primary; bulky stage II base of tongue/hypopharynx or stage II nasopharyngeal cancer also eligible
- ✓Histologically or cytologically confirmed squamous cell carcinoma, poorly differentiated carcinoma, or WHO types I-III nasopharyngeal cancer
- ✓Unidimensionally measurable disease by RECIST
- ✓No prior chemotherapy, biologic/molecular targeted therapy, or radiotherapy for head and neck cancer; prior EGFR pathway-targeting therapy specifically prohibited
- ✕Distant metastasis (M1) at presentation
- ✕History of severe allergic reactions to docetaxel or polysorbate 80-formulated drugs
- ✕Uncontrolled intercurrent illness or significant history of uncontrolled cardiac disease
- ✕Receiving any other investigational agents
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Trial of Docetaxel, Cetuximab (C225), and Cisplatin Followed by Radiation, Cetuximab, and Cisplatin in Locally Advanced Head and Neck Cancer
In Brief
A Phase 2 clinical trial evaluating Docetaxel, Cisplatin, and 2 other interventions for Cancer. Completed, enrolled 39 participants across 1 site.
Detailed Summary
The purpose of this study is to determine if the addition of a unique targeted agent called Cetuximab (also known as "C225" and "Erbitux") can increase the effectiveness of standard treatment with chemotherapy and radiation.
Study Details
Timeline
Interventions
Docetaxel 75 mg/m\^2 IV over 1 hour, day 1
Cisplatin 75 mg/m\^2 IV over 1-2 hours, day 1, 1 hour following completion of cetuximab infusion.
Cetuximab dose will be 250 mg/m\^2 IV over 60 minutes weekly on ALL subsequent administrations (days 8 and 15 of cycle 1 and days 1,8,15 of cycles 2 and 3).
Photon energies of 1.25 to 6 MV and/or appropriate electron energies for boosting the nodes are allowed. Photon energies\>6 MV may be utilized when appropriate to boost target localized centrally.