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

NCT ID: NCT01728233

Last Updated: 2021-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-15
• Study Completion Date: 2018-09-21

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.

Conditions

Penile Neoplasms; Carcinoma, Squamous Cell

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Dacomitinib

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

PF-00299804

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

OTHER

Sponsor Role: lead

Responsible Party

Andrea Necchi

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Necchi, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Roberto Salvioni, MD

Role: STUDY_CHAIR

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Locations

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, , Italy

Countries

Italy

Other Identifiers

INT110/12

Identifier Type: -

Identifier Source: org_study_id