RAD001 and Temozolomide in Patients With Advanced Pancreatic Neuroendocrine Tumors
Completed · Phase 1/Phase 2
Conditions studied: Pancreatic Neuroendocrine Tumor
In brief
This research study will test the safety of RAD001 in combination with temozolomide.
Key facts
- Study ID
- NCT00576680
- Run by
- Dana-Farber Cancer Institute
- People needed
- 43
- Starts
- 2008-05-01
- Expected to finish
- 2019-03-29
- Last updated by the study team
- 2020-07-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Locally unresectable or metastatic pancreatic neuroendocrine tumor
- Radiologic, operative, or pathology reports should document a pancreatic location of tumor
- Patients must have confirmed low-grade or intermediate-grade neuroendocrine carcinoma
- Patients must have at least one measurable site of disease according to RECIST criteria that has not been preciously irradiated
- 18 years of age or older
- Minimum of two weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy
- Prior treatment with chemotherapy is allowed, with the exception of prior treatment with temozolomide or dacarbazine
- No Prior therapy with RAD001 or any other mTOR inhibitor
- ECOG Performance status 0,1 or 2
- Life expectancy 12 weeks or more
- Adequate bone marrow, liver and renal function as outlined in the protocol
- Negative serum pregnancy test
- Fasting serum cholesterol as outlined in protocol
You may not qualify if…
- Prior treatment with any investigational drug within the preceding 4 weeks
- Chronic treatment with systemic steroids or another immunosuppressive agent
- Patients should not receive immunization with attenuated live vaccines during study period or within 1 week of study entry
- Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
- Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinoma of the skin
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
- Women who are pregnant or breast feeding
- Patients who have received prior treatment with an mTOR inhibitor or temozolomide
- Patients with known hypersensitivity to RAD001 or other rapamycins or to its excipients
- History of noncompliance to medical regimens
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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