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Phase I/II Study of RAD001 in Combination With Temozolomide in Patients With Advanced Pancreatic Neuroendocrine Tumors

Phase 1/Phase 2
18 Years
Open (Enrolling)
Pancreatic Neuroendocrine Tumor

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Trial Information

Phase I/II Study of RAD001 in Combination With Temozolomide in Patients With Advanced Pancreatic Neuroendocrine Tumors

- 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.

Inclusion Criteria:

- Locally unresectable or metastatic pancreatic neuroendocrine tumor

- Radiologic, operative, or pathology reports should document a pancreatic location of

- 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

Exclusion Criteria:

- 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

- History of noncompliance to medical regimens

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the objective response rate of RAD001 in combination with temozolomide in patients with advanced pancreatic neuroendocrine tumors.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Jennifer Chan, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

May 2008

Completion Date:

September 2013

Related Keywords:

  • Pancreatic Neuroendocrine Tumor
  • RAD001
  • temozolomide
  • Neuroendocrine Tumors
  • Adenoma, Islet Cell



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617