Clinical Trial: Axitinib (AG-013736) in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Study of Axitinib (AG-013736) in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma

Brief Summary:

The purpose of this study is to find out what effects, good and/or bad, a new treatment called axitinib has on the patient and adenoid cystic carcinoma. This type of cancer study is called a phase II study.

Axitinib is an oral medication that can interfere with cancer cell growth and reduce the growth of blood vessels around tumors. This study will help find out if axitinib is a useful drug for treating patients with adenoid cystic carcinomas. Axitinib is an experimental drug that has not yet been approved by the Food and Drug Administration for use in adenoid cystic carcinoma.

Detailed Summary:
Sponsor: Memorial Sloan Kettering Cancer Center

Current Primary Outcome: overall response rate [ Time Frame: 2 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• median progression-free survival (PFS). [ Time Frame: 2 years ]
  Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
• ACC tumor responses [ Time Frame: 2 years ]
  To evaluate the hypothesis that ACC tumor responses to axitinib are correlated to baseline expression of PDGFR and/or c-myb driven expression of c-kit and VEGFR. Levels of c-kit, VEGF, VEGFR-2, PDGF, PDGFRα/β, and c-myb in archival tumor tissue will be quantified by immunohistochemistry (IHC) and their association with objective response to axitinib will be investigated using the non-parametric Wilcoxon signed-rank test.
• ACC tumors harboring [ Time Frame: 2 years ]
  the t(6;9) translocation (MYBNFIB gene product) are more likely to respond to axitinib.t(6;9) translocation status will be analyzed by Fluorescent In-Situ Hybridization (FISH) assay and correlated to clinical response.

Original Secondary Outcome:

• median progression-free survival (PFS). [ Time Frame: 2 years ]
  Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
• ACC tumor responses [ Time Frame: 2 years ]
  To evaluate the hypothesis that ACC tumor responses to axitinib are correlated to baseline expression of PDGFR and/or c-myb driven expression of c-kit and VEGFR. Levels of c-kit, VEGF, VEGFR-2, PDGF, PDGFRα/β, and c-myb in archival tumor tissue will be quantified by immunohistochemistry (IHC) and their association with objective response to axitinib will be investigated using the non-parametric Wilcoxon signed-rank test.

Dates:
Date Received: March 16, 2012
Date Started: March 2012
Date Completion:
Last Updated: August 18, 2016
Last Verified: August 2016