Capecitabine and Temozolomide for Treatment of Recurrent Pituitary Adenomas
Status:
Recruiting
Trial end date:
2023-09-01
Target enrollment:
Participant gender:
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.