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

NCT01728233 | Completed Phase 2 DMC

• 1 other identifier: INT110/12
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

Molecular Targeted Therapy; Neoadjuvant therapy; Dacomitinib

Outcome Measures

Primary Outcomes (1)

• 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.

  2-months

Secondary Outcomes (5)

• 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.

  2-months

• Pathologic complete response (pCR) rate for patients undergoing surgery in the treatment time course.

  2-months or longer.

• Progression-free survival.

  2-months.

• Overall Survival

  6-months

• Variations of the Quality of Life score as assessed with the Edmonton Symptom Assessment Scale (ESAS), validated in Italian language.

  2-months.

Study Arms (1)

Dacomitinib (PF-00299804)

EXPERIMENTAL

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

Interventions

Dacomitinib 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.

Also known as: PF-00299804

Dacomitinib (PF-00299804)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead
• Pfizer: collaborator

Study Sites (1)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

Location

MeSH Terms

Conditions

Penile Neoplasms; Carcinoma, Squamous Cell

Interventions

dacomitinib

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Penile Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Study Officials

• Andrea Necchi, MD

  Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  PRINCIPAL INVESTIGATOR

• Roberto Salvioni, MD

  Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 13, 2012
• First Posted: November 19, 2012
• Study Start: June 15, 2013
• Primary Completion: September 21, 2018
• Study Completion: September 21, 2018
• Last Updated: May 14, 2021

Record last verified: 2021-05

Locations

IT (1)