NCT03930771

Capecitabine and Temozolomide for Treatment of Recurrent Pituitary Adenomas

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Pituitary Adenomas

Interventions

Type	Name	Description
DRUG	Capecitabine	1500mg/m2 orally per day (divided into two doses with maximum daily dose of 2500mg) on days 1 through 14.
DRUG	Temozolomide	150 to 200 mg/m2 orally on days 10 through 14.

Timeline

• Start date: 2019-05-21
• Primary completion: 2021-08-19
• Completion: 2021-10-01
• First posted: 2019-04-29
• Last updated: 2022-08-09
• Results posted: 2022-08-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study