Clinical Trial: Targeted Therapy With Lapatinib in Patients With Recurrent Pituitary Tumors Resistant to Standard Therapy

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

Official Title: Targeted Therapy With Lapatinib in Patients With Recurrent Pituitary Tumors Resistant to Standard Therapy

Brief Summary:

PURPOSE

The drug Lapatinib has been shown to inhibit both epidermal growth factor receptor (EGFR) and erbB2 tyrosine kinases resulting in an effective slowing of disease progression in breast cancer. It has also been demonstrated that erbB is overexpressed in human pituitary adenomas. The investigators are therefore assessing tumor size stabilization and pituitary tumor secretory profiles during the course of a six month therapy of lapatinib. The purpose of this trial will be to estimate the activity of lapatinib in slowing the growth rate of pituitary tumors. Lapatinib is an FDA approved drug used to treat breast cancer. However, in this study, the drug will be used to treat pituitary cancer.

STUDY POPULATION

This study will recruit patients from the Pituitary Center at CSMC who are over the age of 18 that have a recurrent nonfunctioning adenoma after at least one surgical resection as well as patients with prolactinomas who are resistant to dopamine agonist therapy and patients with recurrent Cushing's disease.

PARTICIPANT'S JOURNEY THROUGH THE RESEARCH

The principal investigator (PI) or co-investigator will determine patients' potential eligibility for the study based on inclusion and exclusion criteria.

The PI or the co-investigator will then approach subjects with recurrent nonfunctioning adenomas or prolactinomas resistant to dopamine agonist therapy or recurrent Cushing's disease during a visit in the clinic office and ask if these subjects would be interested in participating in this study. If the subjects express interest, they will be given the consent form to review. They will be encouraged to review it with family,

Detailed Summary:
Sponsor: Cedars-Sinai Medical Center

Current Primary Outcome:

  • Primary outcome in nonfunctioning adenomas: stabilization of tumor volume and mean tumor diameter on MRI. Stabilization is defined as < 2 mm change in any dimension. MRIs will be performed at baseline and at 3 and 6 months. [ Time Frame: baseline and every 3 months ]
  • Primary outcome in prolactinomas: normalization of prolactin levels. Prolactin levels will be measured at baseline and monthly. [ Time Frame: every month ]


Original Primary Outcome:

  • Primary outcome in nonfunctioning adenomas: stabilization of tumor volume and mean tumor diameter on MRI. Stabilization is defined as < 2 mm change in any dimension. MRIs will be performed at baseline and at 3 and 6 months.
  • Primary outcome in prolactinomas: normalization of prolactin levels. Prolactin levels will be measured at baseline and monthly.


Current Secondary Outcome:

  • Secondary outcomes: measurement of pituitary hormones [ Time Frame: monthly ]
    In both nonfunctioning adenomas and prolactinomas, patients will have pituitary hormone lab testing.
  • Secondary outcome: visual field testing [ Time Frame: every 1-3 months ]
    Patients with preexisting visual field compromise will undergo visual field tests at visits 1-4 and 7. Patients with normal baseline visual field test will undergo visual field testing on visit 1, 4, 7.


Original Secondary Outcome: Secondary outcomes: In both nonfunctioning adenomas and prolactinomas, patients will undergo visual field testing and pituitary hormone profiles. Pituitary hormones and serum EGFR and erbB2 will be assayed at baseline and at 3 and 6 months.

Information By: Cedars-Sinai Medical Center

Dates:
Date Received: July 14, 2009
Date Started: July 2009
Date Completion: July 2018
Last Updated: May 12, 2017
Last Verified: May 2017