Head and Neck Cancer Clinical Trial
Official title:
"Phase II Study of the Combination of Panitumumab With Paclitaxel as First-line Treatment of Subjects With Metastatic or Recurrent Head and Neck Cancer"
The clinical hypothesis of this study is that the first-line treatment with the combination of panitumumab and paclitaxel will provide benefit for patients with metastatic or current Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Panitumumab, a fully human IgG2 anti-EGFR monoclonal antibody, has shown activity in
preclinical models of SCCHN, and promising activity in refractory SCCHN patients in a phase I
clinical trial. Recently, the investigators also reported encouraging outcomes of
anti-EGFR-paclitaxel combination in a phase II study. On the basis of this background, a
phase II clinical trial (VECTITAX study) was designed with the objective of evaluating the
activity and safety profile of panitumumab in combination with paclitaxel in patients with
recurrent or metastatic SCCHN.
The VECTITAX study was a single arm, open label, multicenter, phase II clinical trial. To be
included patients had to have histologically or cytologically confirmed SCCHN. The current
situation had to be recurrent or metastatic, deemed to be untreatable by surgery or
radiotherapy. No previous systemic antineoplastic therapy for the recurrent/metastatic
disease may have been administered. However, previous chemotherapy was allowed as a part of a
multimodality radical treatment if completed >24 weeks before study entry.
Primary endpoint was confirmed objective response rate (ORR) according to RECIST 1.1 criteria
in the intention-to-treat population (ITT). Tumor assessments were planned to be performed
every two months. Response confirmation was to be assessed not before 4 weeks after a partial
or complete response, or before 6 weeks after a stable disease. Secondary endpoints were
disease control rate, time to response, duration of response, progression-free survival
(PFS), OS, safety profile and QoL through EQ-5D-3L with visual analogic scale (VAS). Quality
of life scores were registered at baseline and every eight weeks thereafter.
Treatment consisted of intravenous panitumumab 6 mg/kg q2w, administered in one hour the
first day and in 30 minutes thereafter (if no infusional reaction was observed) plus
intravenous paclitaxel 80 mg/m2 weekly administered one hour after panitumumab in one hour
infusion, until progression or unacceptable toxicity. Panitumumab does not require
prophylactic premedication from the first infusion.
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