Dacomitinib (PF-00299804) in Advanced/Metastatic Squamous Cell Carcinoma of the Penis (HER-Uro01)
This study is not yet open for participant recruitment.
Verified November 2012 by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
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: November 16, 2012
Last verified: November 2012
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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: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]
- Pathologic complete response (pCR) rate for patients undergoing surgery in the treatment time course. [ Time Frame: 2-months or longer. ] [ Designated as safety issue: No ]
- Progression-free survival. [ Time Frame: 2-months. ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: 6-months ] [ Designated as safety issue: No ]
- Variations of the Quality of Life score as assessed with the Edmonton Symptom Assessment Scale (ESAS), validated in Italian language. [ Time Frame: 2-months. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 37 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | April 2016 |
| Estimated Primary Completion Date: | December 2015 (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 |
| Genders 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
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 | Not yet 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
No publications provided
| 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: | November 16, 2012 |
| Health Authority: | Italy: The Italian Medicines Agency |
Keywords provided by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:
|
Molecular Targeted Therapy Neoadjuvant therapy Dacomitinib |
Additional relevant MeSH terms:
|
Penile Diseases Neoplasms Carcinoma Carcinoma, Squamous Cell Penile Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms, Squamous Cell Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male |
ClinicalTrials.gov processed this record on May 21, 2013