NCT01264328

Study of the Combination of Panitumumab With Paclitaxel as First-line Treatment of Subjects With Head and Neck Cancer

"Phase II Study of the Combination of Panitumumab With Paclitaxel as First-line Treatment of Subjects With Metastatic or Recurrent Head and Neck Cancer"

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Grupo Español de Tratamiento de Tumores de Cabeza y Cuello · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Panitumumab + paclitaxel	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.

Timeline

• Start date: 2011-03-09
• Primary completion: 2011-10-01
• Completion: 2014-09-29
• First posted: 2010-12-21
• Last updated: 2019-04-16

Locations

12 sites across 1 country: Spain