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COMPLETED
NCT00113360
PHASE2

RAD001 Plus Octreotide Depot in Metastatic or Unresectable Low Grade Neuroendocrine Carcinoma

Sponsor: M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

Objectives: Primary endpoint: -Assess the clinical activity of RAD 001 plus depot octreotide as defined by progression free survival (PFS) duration defined by RECIST criteria in treated and untreated patients with metastatic, unresectable low grade neuroendocrine carcinoma. Secondary endpoints: * Assess the progression free survival duration of patients with metastatic, unresectable low grade neuroendocrine carcinoma treated with RAD 001 plus depot octreotide. * Assess the safety of RAD 001 plus depot octreotide in patients with metastatic, unresectable low grade neuroendocrine carcinoma. * To determine the expression/phosphorylation status of the components of the mTOR signaling pathway in the primary tumors, in order to determine whether these markers can be used as predictors of sensitivity to the combination of RAD001 and octreotide. * To determine the effect of the combination of RAD001 and octreotide on the expression and phosphorylation of mTOR's targets in the accessible tumor tissue, in order to identify potential pharmacodynamics markers of response to this drug combination. * To observe the effects of treatment with RAD001 on plasma angiogenic biomarkers.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

67

Start Date

2005-01

Completion Date

2009-07

Last Updated

2026-07-06

Healthy Volunteers

No

Interventions

DRUG

RAD001

Starting dose of 5 or 10 mg by mouth daily.

DRUG

Octreotide Depot

30 mg injection into the muscle of either buttock once every 28 (±7) days.

Locations (1)

UT MD Anderson Cancer Center

Houston, Texas, United States