Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00253318
Status:
TERMINATED
Last Update Posted:
2023-10-13
First Post:
2005-11-11
Brief Title:
RAD001 Plus Docetaxel in Patients With Metastatic Breast Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase I Open Label Dose Escalation Study of the Safety Tolerability and Pharmacokinetics of the Combination RAD001 Plus Docetaxel in Patients With Metastatic Breast Cancer
Status:
TERMINATED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Toxicity and Lack of Efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary
To assess the safety and tolerability and to find the maximum tolerated dose of the combination administration of RAD001 plus docetaxel when given to patients with metastatic breast cancer who are being considered for standard docetaxel treatment phase I
To characterize the pharmacokinetics of RAD001 and docetaxel when co-administered phase I
Secondary
To determine the phosphorylation status of the components of the mTOR signaling pathway and the expression of modifiers of apoptosis in the primary breast tumors in order to determine whether these markers can be used as predictors of sensitivity to the combination of RAD001 and docetaxel
To determine the effect of the combination of RAD001 and docetaxel 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 assess the safety and tolerability and to find the maximum tolerated dose of the combination administration of RAD001 plus docetaxel when given to patients with metastatic breast cancer who are being considered for standard docetaxel treatment phase I
To characterize the pharmacokinetics of RAD001 and docetaxel when co-administered phase I
Secondary
To determine the phosphorylation status of the components of the mTOR signaling pathway and the expression of modifiers of apoptosis in the primary breast tumors in order to determine whether these markers can be used as predictors of sensitivity to the combination of RAD001 and docetaxel
To determine the effect of the combination of RAD001 and docetaxel 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
Detailed Description:
Docetaxel is a drug approved for the treatment of metastatic breast cancer in patients who are either newly diagnosed or have failed earlier chemotherapy RAD001 is an investigational drug that has shown to have anticancer properties It also works by weakening the immune system RAD001 works by blocking some of the steps required for cancer growth The researcher hopes that RAD001 may increase the anticancer activity of docetaxel
Before you can start treatment on this 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 have a complete medical history and physical exam Blood between 1-2 teaspoons will be collected for routine tests You will have scans MRI or CT to check on the status of your cancer as ordered by your primary physician Women who are able to have children must have a negative blood pregnancy test As part of the study researchers will also look at the tissue of your original cancer Special stains will be done that will help find ways in which researchers can predict the response of your cancer to RAD001
If you are found to be eligible to take part in this study you will receive docetaxel by vein on Day 1 over one hour RAD001 will be given by mouth on Days 1 and 8 RAD 001 will be given on an empty stomach or after a light meal You will repeat this treatment every 21 days Three 3 weeks equals 1 cycle
Patients who participate on the first part of this study will be enrolled in groups of 3 at a time The dose of RAD001 will be increased with each new group of patients The dose of docetaxel will remain the same The second part of the study will be using the highest dose of RAD001 and docetaxel that was found to be safe and effective during the first part of the study Study did not progress to second part
Dexamethasone will be given by mouth twice a day for 3 days starting the day before you receive docetaxel Dexamethasone helps decrease the risk of and control nausea vomiting and fluid retention
Blood between 1-2 teaspoons will be drawn for routine tests at each visit X-rays and scans CT or MRI will be done every 6 weeks to see if the tumor is responding to treatment
After 6 cycles of the combination docetaxel will be stopped and you will continue to take RAD001 alone However you may be able to take more than 6 cycles of the combination if you are not having any side effects and is found to be of benefit by your primary doctor
Once you go off treatment you will have a physical exam including routine blood tests 1-2 teaspoons
This is an investigational study Docetaxel is approved by the FDA and commercially available for the treatment of breast cancer RAD001 is authorized for use in research only About 65 patients will take part in the study All will be enrolled at M D Anderson
Before you can start treatment on this 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 have a complete medical history and physical exam Blood between 1-2 teaspoons will be collected for routine tests You will have scans MRI or CT to check on the status of your cancer as ordered by your primary physician Women who are able to have children must have a negative blood pregnancy test As part of the study researchers will also look at the tissue of your original cancer Special stains will be done that will help find ways in which researchers can predict the response of your cancer to RAD001
If you are found to be eligible to take part in this study you will receive docetaxel by vein on Day 1 over one hour RAD001 will be given by mouth on Days 1 and 8 RAD 001 will be given on an empty stomach or after a light meal You will repeat this treatment every 21 days Three 3 weeks equals 1 cycle
Patients who participate on the first part of this study will be enrolled in groups of 3 at a time The dose of RAD001 will be increased with each new group of patients The dose of docetaxel will remain the same The second part of the study will be using the highest dose of RAD001 and docetaxel that was found to be safe and effective during the first part of the study Study did not progress to second part
Dexamethasone will be given by mouth twice a day for 3 days starting the day before you receive docetaxel Dexamethasone helps decrease the risk of and control nausea vomiting and fluid retention
Blood between 1-2 teaspoons will be drawn for routine tests at each visit X-rays and scans CT or MRI will be done every 6 weeks to see if the tumor is responding to treatment
After 6 cycles of the combination docetaxel will be stopped and you will continue to take RAD001 alone However you may be able to take more than 6 cycles of the combination if you are not having any side effects and is found to be of benefit by your primary doctor
Once you go off treatment you will have a physical exam including routine blood tests 1-2 teaspoons
This is an investigational study Docetaxel is approved by the FDA and commercially available for the treatment of breast cancer RAD001 is authorized for use in research only About 65 patients will take part in the 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-2010-00840 | REGISTRY | NCI CTRP | None |