Phase II Study of RAD001 Plus Octreotide Depot in Patients With Metastatic or Unresectable Low Grade Neuroendocrine Carcinoma (Carcinoid, Islet Cell)

Inclusion Criteria:

- Patients with histologic proof of low grade neuroendocrine carcinoma will be
eligible. Both carcinoid (any site[atypical/intermediate grade carcinoid is allowed])
and islet cell (pancreatic endocrine tumor) will be eligible.

- Patients with neuroendocrine tumors associated with MEN1 syndrome will be eligible.

- Patients must have either metastatic or unresectable local-regional cancer.

- Patients must have measurable disease, as defined by RECIST (Response Evaluation
Criteria In Solid Tumors).

- Prior and concurrent octreotide (Sandostatin and Sandostatin LAR) is allowed.

- Prior radiation therapy is permitted. A recovery period of at least 4 weeks after
completion of radiotherapy is required prior to enrollment.

- Patients may have received 0, 1, or 2 prior cytotoxic chemotherapy.

- Chemotherapy used as a radiosensitizer will be considered one prior chemotherapy
regimen.

- Patients may have received prior interferon (not counted toward prior cytotoxic
chemotherapy).

- Patients may have received prior therapy targeting c-kit, abl, PDGFR (Platelet
Derived Growth Factor Receptor), VEGF (Vascular endothelial growth factor), or EGFR
[epidermal growth factor receptor] (not counted toward prior cytotoxic chemotherapy).

- Patients may have had prior hepatic artery embolization. There must be residual
measurable disease. Chemoembolization will be considered as one prior chemotherapy
regimen.

- Patients must have a performance status of 0, 1, or 2 (Zubrod scale).

- Patients must be >/= 18 years old (age limit due to lack of adequate safety data in
younger patients).

- Patients must give written informed consent.

- Patients should have adequate organ function defined as follows: Absolute
granulocytes > 1,500/mm3, hemoglobin > 8 g/dl, and platelets > 100,000/mm3. Serum
bilirubin < 1.5 x Upper Limit of Normal (ULN), serum creatinine < 1.5 mg/dL, AST
(SGOT) less/equal 2.5 x ULN, ALT (SGPT) less/equal 2.5 x ULN.

- Patients must have recovered from recent surgery. One week must have elapsed from the
time of a minor surgery and 4 weeks from major surgery.

- Fertile patients, both male and female, must practice contraception during treatment.

Exclusion Criteria:

- Patients may receive no other concurrent chemotherapy, immunotherapy, or
radiotherapy.

- Patients with intolerance to octreotide.

- Patients who have received chemotherapy, immunotherapy, or investigational therapy in
the 30 days prior to registration.

- Patients with uncontrolled diabetes mellitus as defined by fasting blood sugar > 1.5
x ULN.

- Pregnant or lactating women. All women of child-bearing potential must have a
negative pregnancy test prior to entry into the study. All patients of child-bearing
potential must be advised of the importance of avoiding pregnancy and using
appropriate methods of contraception while participating in this investigational
trial. Women who have had menses within the past 2 years, who have not had a tubal
ligation, or bilateral oophorectomy are considered to be of child-bearing potential.
Appropriate methods of contraception include hormonal or barrier method of birth
control; abstinence.

- Serious intercurrent infections, or nonmalignant medical illnesses that are
uncontrolled or whose control may be jeopardized by the complications of this
therapy.

- Psychiatric disorders rendering them incapable of complying with the requirements of
the protocol.

- Osseous metastasis as only site of disease.

- Any concurrent active malignancy other than non-melanoma skin cancers or
carcinoma-in-situ of the cervix. Patients with previous malignancies but without
evidence of disease for > 5 years will be allowed to enter the trial.