RAD001 and Temozolomide in Patients With Advanced Pancreatic Neuroendocrine Tumors
|ClinicalTrials.gov Identifier: NCT00576680|
Recruitment Status : Active, not recruiting
First Posted : December 19, 2007
Last Update Posted : August 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Neuroendocrine Tumor||Drug: RAD001 Drug: Temozolomide||Phase 1 Phase 2|
- Participants will take RAD001 by mouth daily. They will also take temozolomide by mouth daily for one week, followed by a one-week break period. This one-week on/one week off schedule for temozolomide will continue for the duration of the treatment.
- After the first month of treatment, there will be a 7-day observation period during which no study medication will be taken to observe for any side effects.
- During all treatment cycles (1 cycle is 28 days in length) participants will have a physical exam and will be asked questions about their general health and specific questions about any problems they may be experiencing. Initially, participants will come in every other week. At each of these visits, blood work will be taken to monitor the participants health.
- After every 2 months of treatment, participants will have a CT scan or MRI done to see how the medication is working.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of RAD001 in Combination With Temozolomide in Patients With Advanced Pancreatic Neuroendocrine Tumors|
|Study Start Date :||May 2008|
|Estimated Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||December 2017|
- To determine the objective response rate of RAD001 in combination with temozolomide in patients with advanced pancreatic neuroendocrine tumors. [ Time Frame: 2 years ]
- To determine the duration of response to the combination of RAD001 and temozolomide in this patient population. [ Time Frame: 2 years ]
- To determine the safety and tolerability of this drug combination. [ Time Frame: 2 years ]
- To determine the progression free survival and overall survival of patients receiving this combination. [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00576680
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Jennifer Chan, MD, PhD||Dana-Farber Cancer Institute|