Clinical trial NCT01728233: Dacomitinib (PF-00299804) in Advanced/Metastatic Squamous Cell Carcinoma of the Penis
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Penile Neoplasms
Carcinoma, Squamous Cell
Keywords: Molecular Targeted Therapy
Neoadjuvant therapy
Dacomitinib
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2012-11-19
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: The primary outcome measure will be the assessment of response-rate (RR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
timeFrame: 2-months
Secondary outcomes:
measure: 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.
timeFrame: 2-months
measure: Pathologic complete response (pCR) rate for patients undergoing surgery in the treatment time course.
timeFrame: 2-months or longer.
measure: Progression-free survival.
timeFrame: 2-months.
measure: Overall Survival
timeFrame: 6-months
measure: Variations of the Quality of Life score as assessed with the Edmonton Symptom Assessment Scale (ESAS), validated in Italian language.
timeFrame: 2-months.
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
Study officials:
affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
name: Andrea Necchi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
name: Roberto Salvioni, MD
role: STUDY_CHAIR
References: