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Clinical Trial Summary

This is an open label study to assess the efficacy of capecitabine (CAP) and temozolomide (TMZ) in recurrent pituitary adenomas. There will be a safety run-in of at least three patients to establish any dose limiting toxicities. Enrolled patients will receive treatment in 28-day cycles: capecitabine 1500mg/m2 per day (divided into two doses with maximum daily dose of 2500mg) on days 1 through 14 and oral temozolomide 150 to 200 mg/m2 on days 10 through 14. This will be followed by 14 days off treatment. MRI imaging will be completed after every two cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03930771
Study type Interventional
Source Weill Medical College of Cornell University
Contact
Status Terminated
Phase Phase 2
Start date May 21, 2019
Completion date October 1, 2021