Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113360
Status:
COMPLETED
Last Update Posted:
2023-10-25
First Post:
2005-06-07
Brief Title:
RAD001 Plus Octreotide Depot in Metastatic or Unresectable Low Grade Neuroendocrine Carcinoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Study of RAD001 Plus Octreotide Depot in Patients With Metastatic or Unresectable Low Grade Neuroendocrine Carcinoma Carcinoid Islet Cell
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 expressionphosphorylation 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 mTORs 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
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 expressionphosphorylation 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 mTORs 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
Detailed Description:
RAD001 is a new drug that is designed to block a protein that is important in the growth of cancer cells Octreotide Depot is FDA approved for the treatment of carcinoid syndrome and hormonal symptoms from certain islet cell carcinomas Octreotide Depot may also help to block certain proteins that are important in tumor growth
Before you can start treatment on the study you will have what are called screening tests These tests will help the doctor decide if you are eligible to take part in the study You will be asked questions about your medical history and about any medications you are currently taking or have taken in the past You will have a complete physical exam and your heart rate temperature breathing rate blood pressure height and weight will be measured You will be asked about your ability to perform every day activities Blood about 2 teaspoons will be collected for routine tests You will have an electrocardiogram ECG - a test that measures the electrical activity of the heart and scans either Computed TomographyCT or Magnetic Resonance ImagingMRI to evaluate the cancer Women who are able to have children must have a negative blood pregnancy test
If the screening evaluations show you are eligible to take part in the study you may begin treatment You will take RAD001 by mouth once a day every day while on study You should take it in a fasting state or after no more than a light fat-free meal You should take RAD001 about the same time each day Octreotide Depot will be given as an injection into the muscle of either buttock once every 4 weeks while on study This will be done at M D Anderson Four weeks 28 days is called one course of treatment
Clinic visits will occur every 2 weeks during the first 4 weeks and every 4 weeks from then on At each clinic visit you will be asked questions about your medical history and about any medications you are currently taking or have taken in the past You will have a complete physical exam and your heart rate temperature breathing rate blood pressure height and weight will be measured You will be asked about your ability to perform every day activities Blood samples about 1 teaspoons for routine tests will be collected every 2 weeks for the first 8 weeks After that blood samples about 2 teaspoons will be collected every 4 weeks CT or MRI scans will be performed every 12 weeks
If a sample of your tumor tissue that was removed previously is available it will be analyzed for expression of proteins that may effect tumor growth However if a sample is not available you will not be asked to undergo a biopsy to collect this tissue This sample may analyzed at any time during the study
If you experience severe side effects treatment may be delayed stopped or you may receive smaller doses of RAD001 andor Octreotide Depot You may continue to receive up to at least 12 courses of study treatment unless the disease gets worse you decide not to take part any longer or your doctor decides it is in your best interest to stop treatment It may be possible to continue treatment beyond 12 courses if you are benefitting from this treatment
When you stop study treatment you will be asked to have some tests and evaluations done About 4 teaspoons of blood will be taken for routine lab tests You will also have a physical exam and CT scan or MRI scan will be done to check the size and location of your disease
This is an investigational study RAD001 is investigational and is not commercially available The drug combination in this study is also investigational RAD001 is manufactured by Novartis Pharmaceuticals Corporation About 60 patients will take part in this study All will be enrolled at M D Anderson
Before you can start treatment on the study you will have what are called screening tests These tests will help the doctor decide if you are eligible to take part in the study You will be asked questions about your medical history and about any medications you are currently taking or have taken in the past You will have a complete physical exam and your heart rate temperature breathing rate blood pressure height and weight will be measured You will be asked about your ability to perform every day activities Blood about 2 teaspoons will be collected for routine tests You will have an electrocardiogram ECG - a test that measures the electrical activity of the heart and scans either Computed TomographyCT or Magnetic Resonance ImagingMRI to evaluate the cancer Women who are able to have children must have a negative blood pregnancy test
If the screening evaluations show you are eligible to take part in the study you may begin treatment You will take RAD001 by mouth once a day every day while on study You should take it in a fasting state or after no more than a light fat-free meal You should take RAD001 about the same time each day Octreotide Depot will be given as an injection into the muscle of either buttock once every 4 weeks while on study This will be done at M D Anderson Four weeks 28 days is called one course of treatment
Clinic visits will occur every 2 weeks during the first 4 weeks and every 4 weeks from then on At each clinic visit you will be asked questions about your medical history and about any medications you are currently taking or have taken in the past You will have a complete physical exam and your heart rate temperature breathing rate blood pressure height and weight will be measured You will be asked about your ability to perform every day activities Blood samples about 1 teaspoons for routine tests will be collected every 2 weeks for the first 8 weeks After that blood samples about 2 teaspoons will be collected every 4 weeks CT or MRI scans will be performed every 12 weeks
If a sample of your tumor tissue that was removed previously is available it will be analyzed for expression of proteins that may effect tumor growth However if a sample is not available you will not be asked to undergo a biopsy to collect this tissue This sample may analyzed at any time during the study
If you experience severe side effects treatment may be delayed stopped or you may receive smaller doses of RAD001 andor Octreotide Depot You may continue to receive up to at least 12 courses of study treatment unless the disease gets worse you decide not to take part any longer or your doctor decides it is in your best interest to stop treatment It may be possible to continue treatment beyond 12 courses if you are benefitting from this treatment
When you stop study treatment you will be asked to have some tests and evaluations done About 4 teaspoons of blood will be taken for routine lab tests You will also have a physical exam and CT scan or MRI scan will be done to check the size and location of your disease
This is an investigational study RAD001 is investigational and is not commercially available The drug combination in this study is also investigational RAD001 is manufactured by Novartis Pharmaceuticals Corporation About 60 patients will take part in this study All will be enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None