Clinical Trial: Dacomitinib (PF-00299804) in Advanced/Metastatic Squamous Cell Carcinoma of the Penis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase II Study of the Pan-HER Inhibitor Dacomitinib (PF-00299804) for Patients With Locally Advanced or Metastatic Squamous Cell Carcinoma of the Penis.

Brief Summary: Penile squamous cell carcinoma (SCC) is a very rare disease and prognosis depends primarily on regional lymph-node involvement. Despite the fact that cure can be obtained in patients with low metastatic load (pN1) by monotherapy, combination therapy is required for more advanced cases. Medical treatment options only for advanced or metastatic penile SCC are not very effective so far and the few chances for cure are solely dependent on multimodality treatment, either with surgery or radiation. Based on the observation that the epidermal growth factor receptor (EGFR) is almost invariably expressed in penile SCC and assuming similarities to the SCC of head and neck district, anti-EGFR targeted monotherapy has been investigated with promising early results at Istituto Tumori Milan and University of Texas MD Andreson Cancer Center. These premises lend support to the use of the pan-HER inhibitor dacomitinib for advanced or metastatic penile SCC.

Detailed Summary:
Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Current Primary Outcome: The primary outcome measure will be the assessment of response-rate (RR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. [ Time Frame: 2-months ]

RR (%) = complete response (CR) + partial response (PR), where CR is the disappearance of all target lesions (any pathological lymph-nodes must have reduction in short axis to < 10 mm) and PR indicates at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • To assess the safety and tolerability of the study drug. Incidence, nature and severity of treatment-related adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v4.0. [ Time Frame: 2-months ]
  • Pathologic complete response (pCR) rate for patients undergoing surgery in the treatment time course. [ Time Frame: 2-months or longer. ]
  • Progression-free survival. [ Time Frame: 2-months. ]
  • Overall Survival [ Time Frame: 6-months ]
  • Variations of the Quality of Life score as assessed with the Edmonton Symptom Assessment Scale (ESAS), validated in Italian language. [ Time Frame: 2-months. ]


Original Secondary Outcome: Same as current

Information By: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Dates:
Date Received: November 13, 2012
Date Started: June 15, 2013
Date Completion: February 15, 2018
Last Updated: March 8, 2017
Last Verified: March 2017