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Dacomitinib (PF-00299804) in Advanced/Metastatic Squamous Cell Carcinoma of the Penis (HER-Uro01)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Andrea Necchi, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier:
NCT01728233
First received: November 13, 2012
Last updated: March 8, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention Phase
Penile Neoplasms
Carcinoma, Squamous Cell
Drug: Dacomitinib
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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. ]

Estimated Enrollment: 37
Actual Study Start Date: June 15, 2013
Estimated Study Completion Date: February 15, 2018
Estimated Primary Completion Date: October 15, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dacomitinib (PF-00299804)
PF-299804 will be administered orally at a dose of 45 mg/day continuously until surgery, evidence of disease progression or onset of unacceptable toxicity.
Drug: Dacomitinib
PF-299804 will be administered orally at a dose of 45 mg/day continuously until surgery, evidence of disease progression or onset of unacceptable toxicity.
Other Name: PF-00299804

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must provide written informed consent
  • Eastern Cooperative Oncology Group performance status of at least 1
  • Cytologically or histologically proven diagnosis of SCC of the penis
  • Uni- or bidimensionally measurable disease as defined by RECIST v1.1 criteria
  • Clinical stage N2-3 and/or M1 (TNM 2002)
  • Locoregional relapse after prior major surgery/ies (either single or multiple)
  • No prior systemic therapy except for the administration of vincristine-bleomycin-methotrexate (VBM) chemotherapy for superficial disease if administered at least 6 months prior to study enrollment
  • Adequate bone marrow, liver and renal function

Exclusion Criteria:

  • Central nervous system (CNS) metastases or leptomeningeal carcinomatosis
  • History of active serious cardiovascular, cerebrovascular, pulmonary co-morbidities
  • Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma or any cancer curatively treated > 5 years prior to study entry.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01728233

Contacts
Contact: Andrea Necchi, MD +39-02-2390-2402 andrea.necchi@istitutotumori.mi.it
Contact: Roberto Salvioni, MD +39-02-2390-2359 roberto.salvioni@istitutotumori.mi.it

Locations
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori Recruiting
Milan, Italy, 20133
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Pfizer
Investigators
Principal Investigator: Andrea Necchi, MD Fondazione IRCCS Istituto Nazionale dei Tumori
Study Chair: Roberto Salvioni, MD Fondazione IRCCS Istituto Nazionale dei Tumori
  More Information

Responsible Party: Andrea Necchi, MD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT01728233     History of Changes
Other Study ID Numbers: INT110/12
Study First Received: November 13, 2012
Last Updated: March 8, 2017

Keywords provided by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:
Molecular Targeted Therapy
Neoadjuvant therapy
Dacomitinib

Additional relevant MeSH terms:
Penile Diseases
Carcinoma
Carcinoma, Squamous Cell
Penile Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male

ClinicalTrials.gov processed this record on March 24, 2017