Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087685
Status:
COMPLETED
Last Update Posted:
2023-10-25
First Post:
2004-07-12
Brief Title:
RAD001 in Recurrent Endometrial Cancer Patients
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Study of RAD001 in Patients With Recurrent Endometrial Cancer
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:
The goal of this clinical research study is to learn if RAD001 can shrink or slow the growth of tumors in patients who have recurrent endometrial cancer The safety of this drug will also be studied
Objectives
Primary Objective
1 To determine the efficacy of RAD001 in patients with progressive or recurrent endometrial cancer
Secondary Objective
1 To determine the nature and degree of toxicity of RAD001 in this cohort of patients
2 To characterize in pre- and post- treatment tumor samples when available expression levels of total and phosphorylated mTOR mammalian target of rapamycin as well as relevant upstream and downstream signaling components optional
Objectives
Primary Objective
1 To determine the efficacy of RAD001 in patients with progressive or recurrent endometrial cancer
Secondary Objective
1 To determine the nature and degree of toxicity of RAD001 in this cohort of patients
2 To characterize in pre- and post- treatment tumor samples when available expression levels of total and phosphorylated mTOR mammalian target of rapamycin as well as relevant upstream and downstream signaling components optional
Detailed Description:
RAD001 is a new drug that was designed to block proteins that are important in the development and growth of cancer
Before treatment starts you will have a complete physical exam routine blood tests about 2-3 teaspoons a chest x-ray and a CT scan or MRI of the abdomen and pelvis Women who are able to have children must have a negative blood pregnancy test
Routine blood tests about 2 teaspoons will be done weekly during treatment and before each course of therapy which is every 4 weeks A complete checkup including evaluation of side effects will also be done before each course of therapy and at the end of therapy 4 weeks after treatment ends
You will take RAD001 10 mg by mouth every day One course of therapy is 4 weeks long RAD001 should be taken the same time every day on an empty stomach fasting state or after no more than a light fat-free meal You should wait at least 6 hours after a eating a regular not fat-free meal before taking RAD001 You should not eat fatty foods for at least one hour after taking RAD001
If side effects occur at this dose your doctor may lower the RAD001 dose depending on the severity of the side effects After an additional 4 weeks of therapy if the dose was reduced and the side effects have resolved your doctor may increase the dose back to the original dose or you may continue at the reduced dose
You will only be given the amount of drug needed for one course of therapy at a time You will keep a diary during the study that will list when and how much drug you took This diary will be reviewed after each course of therapy by the research nurse or physician and filed in your chart
You will have CT or MRI scans and chest x-rays only in patients with chest disease to evaluate the response of your tumor to treatment These scans will be done after the first two courses eight weeks and every third course every 12 weeks and at the end of therapy Treatment will be stopped if the disease gets worse or intolerable side effects occur
This is an investigational study RAD001 has been authorized by the FDA for use in research only Up to 35 patients will take part in this study All will be enrolled at M D Anderson
Before treatment starts you will have a complete physical exam routine blood tests about 2-3 teaspoons a chest x-ray and a CT scan or MRI of the abdomen and pelvis Women who are able to have children must have a negative blood pregnancy test
Routine blood tests about 2 teaspoons will be done weekly during treatment and before each course of therapy which is every 4 weeks A complete checkup including evaluation of side effects will also be done before each course of therapy and at the end of therapy 4 weeks after treatment ends
You will take RAD001 10 mg by mouth every day One course of therapy is 4 weeks long RAD001 should be taken the same time every day on an empty stomach fasting state or after no more than a light fat-free meal You should wait at least 6 hours after a eating a regular not fat-free meal before taking RAD001 You should not eat fatty foods for at least one hour after taking RAD001
If side effects occur at this dose your doctor may lower the RAD001 dose depending on the severity of the side effects After an additional 4 weeks of therapy if the dose was reduced and the side effects have resolved your doctor may increase the dose back to the original dose or you may continue at the reduced dose
You will only be given the amount of drug needed for one course of therapy at a time You will keep a diary during the study that will list when and how much drug you took This diary will be reviewed after each course of therapy by the research nurse or physician and filed in your chart
You will have CT or MRI scans and chest x-rays only in patients with chest disease to evaluate the response of your tumor to treatment These scans will be done after the first two courses eight weeks and every third course every 12 weeks and at the end of therapy Treatment will be stopped if the disease gets worse or intolerable side effects occur
This is an investigational study RAD001 has been authorized by the FDA for use in research only Up to 35 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-01308 | REGISTRY | NCI CTRP | None |