Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT00113360 |
Other study ID # |
2004-0597 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 2
|
First received |
|
Last updated |
|
Start date |
January 2005 |
Est. completion date |
July 2009 |
Study information
Verified date |
October 2023 |
Source |
M.D. Anderson Cancer Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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
Tomography/CT or Magnetic Resonance Imaging/MRI) 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 scan(s) 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 and/or 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.