RAD001 and Temozolomide in Patients With Advanced Pancreatic Neuroendocrine Tumors

• Register: ClinicalTrials.gov
• Last refreshed on: 29 April 2013
• Main ID: NCT00576680
• Date of registration: 17/12/2007
• Primary sponsor: Dana-Farber Cancer Institute
• Public title: RAD001 and Temozolomide in Patients With Advanced Pancreatic Neuroendocrine Tumors
• Scientific title: Phase I/II Study of RAD001 in Combination With Temozolomide in Patients With Advanced Pancreatic Neuroendocrine Tumors
• Date of first enrolment: May 2008
• Target sample size: 12
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00576680
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Jennifer Chan, MD, PhD
• Affiliation: Dana-Farber Cancer Institute

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

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
excipients

- History of noncompliance to medical regimens



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Pancreatic Neuroendocrine Tumor

Intervention(s)

Drug: RAD001

Drug: Temozolomide

Primary Outcome(s)

To determine the objective response rate of RAD001 in combination with temozolomide in patients with advanced pancreatic neuroendocrine tumors. [Time Frame: 2 years]

Secondary Outcome(s)

To determine the duration of response to the combination of RAD001 and temozolomide in this patient population. [Time Frame: 2 years]

To determine the progression free survival and overall survival of patients receiving this combination. [Time Frame: 2 years]

To determine the safety and tolerability of this drug combination. [Time Frame: 2 years]

Secondary ID(s)

07-325

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Beth Israel Deaconess Medical Center

Brigham and Women's Hospital

Massachusetts General Hospital

Novartis

Schering-Plough