Capecitabine and Temozolomide for Treatment of Recurrent Pituitary Adenomas

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.

Timeline

Start

2019-05-21

Primary completion

2021-08-19

Completion

2021-10-01

Outcome

Outcome not reported

Stopped (Enrollment): “the study had a low accrual rate”

Drugs

Indications