Back to resultsDacomitinib (PF-00299804) in Advanced/Metastatic Squamous Cell Carcinoma of the Penis (HER-Uro01)
Primary Purpose
Penile Neoplasms, Carcinoma, Squamous Cell
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Dacomitinib
Sponsored by
About this trial
This is an interventional treatment trial for Penile Neoplasms focused on measuring Molecular Targeted Therapy, Neoadjuvant therapy, Dacomitinib
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.
Sites / Locations
- Fondazione IRCCS Istituto Nazionale dei Tumori
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dacomitinib (PF-00299804)
Arm Description
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.
Outcomes
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.
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.
Pathologic complete response (pCR) rate for patients undergoing surgery in the treatment time course.
Progression-free survival.
Overall Survival
Variations of the Quality of Life score as assessed with the Edmonton Symptom Assessment Scale (ESAS), validated in Italian language.
Full Information
NCT ID
NCT01728233
First Posted
November 13, 2012
Last Updated
May 12, 2021
Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT01728233
Brief Title
Dacomitinib (PF-00299804) in Advanced/Metastatic Squamous Cell Carcinoma of the Penis
Acronym
HER-Uro01
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
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 15, 2013 (Actual)
Primary Completion Date
September 21, 2018 (Actual)
Study Completion Date
September 21, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Penile Neoplasms, Carcinoma, Squamous Cell
Keywords
Molecular Targeted Therapy, Neoadjuvant therapy, Dacomitinib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dacomitinib (PF-00299804)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dacomitinib
Other Intervention Name(s)
PF-00299804
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary outcome measure will be the assessment of response-rate (RR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Description
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.
Time Frame
2-months
Secondary Outcome Measure Information:
Title
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
Title
Pathologic complete response (pCR) rate for patients undergoing surgery in the treatment time course.
Time Frame
2-months or longer.
Title
Progression-free survival.
Time Frame
2-months.
Title
Overall Survival
Time Frame
6-months
Title
Variations of the Quality of Life score as assessed with the Edmonton Symptom Assessment Scale (ESAS), validated in Italian language.
Time Frame
2-months.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Necchi, MD
Organizational Affiliation
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roberto Salvioni, MD
Organizational Affiliation
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Official's Role
Study Chair
Facility Information:
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milan
ZIP/Postal Code
20133
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Dacomitinib (PF-00299804) in Advanced/Metastatic Squamous Cell Carcinoma of the Penis
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