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Phase I dose-finding study of paclitaxel with panitumumab, carboplatin and intensity-modulated radiotherapy in patients with locally advanced squamous cell cancer of the head and neck
Annals of Oncology, 11/10/09
Wirth LJ et al. – Panitumumab, carboplatin, paclitaxel and IMRT are well tolerated and appear highly active in the treatment of SCCHN.
Methods- Phase I dose-finding study investigated escalating doses of paclitaxel (Taxol) given concurrently with panitumumab, carboplatin and intensity-modulated radiotherapy (IMRT) for stage III–IVB SCCHN
- Untreated patients with oral cavity, oropharynx, larynx, hypopharynx or unknown primaries eligible
- Additional eligibility criteria included measurable disease, good performance status and no contraindication to therapy
- Patients received weekly fixed doses of panitumumab and carboplatin plus escalating doses of paclitaxel with IMRT
- 19 patients enrolled on to 2 dose levels (DLs): weekly paclitaxel 15 mg/m2 (n = 3) and 30 mg/m2
- 1 dose-limiting toxicity occurred in DL 2, which was declared maximum tolerated dose
- All patients experienced mucositis, primarily grade 3 or more
- Oral pain, xerostomia, dysphagia, weight loss, dermatitis, nausea and acneiform rash were frequent
- All patients had partial response according to RECIST, whereas overall complete clinical response rate was 95%
- Median follow-up of 21 months, 18 of 19 patients (95%) remained disease free
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