Clinical trial NCT00576680: RAD001 and Temozolomide in Patients With Advanced Pancreatic Neuroendocrine Tumors
Official title: Phase I/II Study of RAD001 in Combination With Temozolomide in Patients With Advanced Pancreatic Neuroendocrine Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pancreatic Neuroendocrine Tumor
Keywords: RAD001
temozolomide
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
name: Brigham and Women's Hospital
name: Massachusetts General Hospital
name: Novartis
name: Schering-Plough
First posted: 2007-12-19
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research study will test the safety of RAD001 in combination with temozolomide.

Detailed description: * 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.

Eligibility 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

Primary outcomes:
measure: Response Rate
timeFrame: 2 years
Secondary outcomes:
measure: Progression-free Survival
timeFrame: 2 years
measure: To Determine the Safety and Tolerability of This Drug Combination.
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Jennifer Chan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: