Clinical Trial: Abiraterone Acetate in Patients With Relapsed and/or Metastatic Salivary Gland Cancers

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase II Trial of Abiraterone Acetate in Patients With Relapsed and/or Metastatic, Castration Resistant Salivary Gland Cancers

Brief Summary: Carcinomas of the salivary glands (SGCs) are rare tumors. Some selected salivary gland histotypes such as salivary duct carcinomas (SDC) and adenocarcinomas, NOS (not otherwise specified) distinguish themselves for the expression of androgen receptors (AR), which is reported in 21% to 43% of the cases. Thus, similarly to prostate cancer (Pca), androgen deprivation therapy (ADT) has been suggested to be beneficial in patients with recurrent or disseminated AR-expressing disease. No other therapy except palliative chemotherapy is available after progression on ADT, thus underling the necessity of alternative therapeutic approaches.

Detailed Summary:

Carcinomas of the salivary glands (SGC) are rare tumors. They comprise less than 1% of all cancers of the head and neck. The standard treatment is surgical excision, followed by radiotherapy in selected cases, such as high-grade tumors, and/or in the presence of perineural invasion, and/or in the presence of advanced disease. Some selected salivary gland histotypes such as salivary duct carcinomas (SDC) and adenocarcinomas, NOS (not otherwise specified) distinguish themselves for the expression of androgen receptors (AR), which is reported in 21% to 43% of the cases. Thus, similarly to prostate cancer (Pca), androgen deprivation therapy (ADT) has been suggested to be beneficial in patients with recurrent or disseminated AR-expressing disease.

The proven activity of ADT in AR expressing SGC as well as in Pca, suggests a common clinical behaviour by apparently sharing the same biological background. Once Pca becomes resistant to castration it still remains driven by ligand-dependent AR signaling and further hormonal manipulations are active and efficacious. Abiraterone acetate is currently approved by FDA for castration-resistant prostate cancer (CRPC). We treated with abiraterone two patients with AR-positive adenocarcinoma who had progressed on ADT, both patients showed a partial response suggesting the activity of a second line hormonal therapy in SGCs.

Based on the above biological and clinical evidences, the aim of the trial is to assess the activity of abiraterone in AR-expressing castration resistant SGCs.


Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Current Primary Outcome: Response rate [ Time Frame: 4 years ]

The assessment of the activity considered as the response rate of abiraterone acetate in castration resistant salivary glands cancer


Original Primary Outcome: Response rate [ Time Frame: 4 years ]

The assessment of the activity cosidered as the response rate of abiraterone acetate in castration resistant salivary glands cancer


Current Secondary Outcome:

  • Disease Control Rate [ Time Frame: 4 years ]
    The assessment of disease control rate of abiraterone acetate in castration resistant salivary glands cancer
  • Adverse Events incidence [ Time Frame: 4 years ]
    Incidence of adverse events, according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.0
  • Progression free survival [ Time Frame: 4 years ]
    The assessment of progression free survival of patients suffering from castration resistant salivary glands cancer enrolled and treated wuth abiraterone acetate
  • Overall survival [ Time Frame: 4 years ]
    The assessment of overall survival of patients suffering from castration resistant salivary glands cancer enrolled and treated wuth abiraterone acetate


Original Secondary Outcome: Same as current

Information By: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Dates:
Date Received: August 11, 2016
Date Started: March 2015
Date Completion: December 2017
Last Updated: August 22, 2016
Last Verified: August 2016