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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Paclitaxel 80 mg/m2 may be infused, intravenously, over one hour every week. Panitumumab will be administered every 2 weeks at a dose of 6 mg/kg, using a non pyrogenic low protein binding filter with a 0.20-0.22-μm pore size intravenously over 1 hour ± 15 minutes. Panitumumab will be administered prior to paclitaxel.
Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital de Navarra
Pamplona, Navarre, Spain
Hospital Clínic i Provincial de Barcelona
Barcelona, Spain
objective response rate
To assess the effect of the combination of panitumumab and paclitaxel on objective response rate in first-line treatment of metastatic or recurrent squamous cell carcinoma of head and neck (SCCHN).
Time frame: 2 years
Time to response, duration of response, progression free-survival, overall survival.
Secondary Objectives * To assess the disease control rate, time to response, duration of response, progression free-survival and overall survival. * To estimate changes in patient-reported outcomes (PRO). * To describe the safety profile of the combination of panitumumab and paclitaxel. 1.3 Exploratory Objectives: * To investigate the effects of genetic variation in cancer genes and drug target genes on subject response to panitumumab and Paclitaxel combination chemotherapy. * To investigate the predictive potential of different biomarkers on efficacy and/or safety endpoints.
Time frame: 2 years
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Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital General de Yagüe
Burgos, Spain
H. Virgen de las Nieves
Granada, Spain
Hospital Universitario Fundación Alcorcón
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario de Salamanca
Salamanca, Spain
Hospital General Universitario
Valencia, Spain
...and 2 more locations