Capecitabine and Temozolomide for Treatment of Recurrent Pituitary Adenomas (TMZ-Cap)
|ClinicalTrials.gov Identifier: NCT03930771|
Recruitment Status : Active, not recruiting
First Posted : April 29, 2019
Last Update Posted : May 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Pituitary Adenomas||Drug: Capecitabine Drug: Temozolomide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Capecitabine and Temozolomide for Treatment of Recurrent Pituitary Adenomas|
|Actual Study Start Date :||May 21, 2019|
|Estimated Primary Completion Date :||September 1, 2023|
|Estimated Study Completion Date :||September 1, 2023|
Experimental: All Patients
All subjects will receive:
After completion of 6 cycles, patients achieving a complete or partial tumor response may continue to receive capecitabine temozolomide at the investigator's discretion in the absence of disease progression or unacceptable toxicity. Patients will be monitored for six months after they come off the study (either after completing 6 cycles or in setting of disease progression or unacceptable toxicity).
1500mg/m2 orally per day (divided into two doses with maximum daily dose of 2500mg) on days 1 through 14.
150 to 200 mg/m2 orally on days 10 through 14.
- Number of subjects with Radiographic Response, as defined by the RECIST criteria. [ Time Frame: 6 months ]
- Effect of the CAP and TMZ combination on pituitary function, measured by changes in pituitary hormone secretion in patients [ Time Frame: At baseline and every 8 weeks, up to 6 months ]Serum prolactin, IGF-1, ACTH, FSH, LH and TSH levels are used to assess changes in pituitary hormone function. These tests will only be repeated if found to be abnormal at baseline.
- Safety, as measured by the number of subjects with at least one AE [ Time Frame: 6 months ]
- Tolerability of the TMZ and Capecitabine combination, as measured by number of participants with a dose-limiting toxicity [ Time Frame: 6 months ]
- Tumor invasiveness and aggressiveness, determined by assessing the relationship between select indicators with response to chemotherapy, time to progression, and tumor invasiveness. [ Time Frame: 6 months ]Tumor invasiveness and aggressiveness, determined by assessing the relationship between select indicators (including Ki67 nuclear labelling index, p53 expression, MGMT expression/methylation status, and additional tumor genetic profiling) with response to chemotherapy, time to progression, and tumor invasiveness (based on the Knosp criteria).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930771
|United States, New York|
|Weill Cornell Medical College|
|New York, New York, United States, 10065|
|Principal Investigator:||Rajiv Magge, MD||Weill Medical College of Cornell University|