Skin Squamous Cell Cancer Clinical Trial
Official title:
Efficacy and Safety of Single Agent Pan-HER Inhibitor Dacomitinib in the Treatment of Locally Advanced Unresectable or Metastatic Squamous Cell Cancer of the Skin or With Clinical Contraindication to Surgery
This is an open label, monocentric, uncontrolled phase II trial with Dacomitinib, a pan-HER
inhibitor, in unresectable or metastatic skin SCC.
HER2 expression is common in skin SCC, being reported with high rates, even if in small
studies.
Coexpression of EGFR, HER2 and HER3 is present in skin SCCs but not in normal skin and it
could be associated with the malignant phenotype. In this frame Dacomitinib could play a
role in the increase of the response rate.
| Status | Active, not recruiting |
| Enrollment | 43 |
| Est. completion date | November 2016 |
| Est. primary completion date | November 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Signed informed consent to treatment - Histological diagnosis of squamous cell carcinoma of the skin not amenable to surgical treatment with curative purposes or with clinical contraindication to surgery (examples of medical contraindications to surgery include but are not limited to: skin SCC that has recurred in the same location after two or more surgical procedures and curative resection is deemed unlikely; anticipated substantial morbidity and/or deformity from surgery (e.g., removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation); anticipated difficulty in obtaining a curative resection due to the location of the tumour, the size of disease; anticipated difficulty in reconstructing the area that will be surgically removed; significant comorbidities that preclude the feasibility of a radical surgery - Presence of measurable disease according to RECIST 1.1 - ECOG performance status 0-2 - Age= 18 years - For men and women in the fertile period: the use of birth control systems during treatment Exclusion Criteria: - Previous treatment with tyrosine kinase inhibitors or monoclonal antibodies directed against EGFR - Any toxicity CTC grade> 2 from previous treatments not yet resolved - Pregnant or breastfeeding |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Italy | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Milan |
| Lead Sponsor | Collaborator |
|---|---|
| Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Analysis of mutational/gene expression | Translational research regarding the analysis of pERK, Ki67, pSTAT3 p27, pEGFR and other mutational/gene expression analysis to be determined within the study period. Correlation of immunohistochemistry analysis of these markers and response to treatment or to onset of acquired resistance. | 24 months | No |
| Primary | Response rate to Dacomitinib | Response rate (partial response, PR + complete response, CR) to Dacomitinib | 24 months | No |
| Secondary | Compliance to the treatment and safety | Compliance to the treatment and safety | 24 months | No |
| Secondary | Disease control | Disease control (stable disease (SD) + PR + CR) | 24 months | No |
| Secondary | PFS and OS | Progression-Free Survival (PFS) and Overall Survival (OS) | 24 months | No |
| Secondary | Percentage of patients initially not considered for surgery due to difficulty to obtain a curative treatment that undergo surgery after dacomitinib | Percentage of patients initially not considered for surgery due to difficulty to obtain a curative treatment that undergo surgery after dacomitinib | 24 months | No |