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Tracking Information | |||||
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First Received Date ICMJE | July 12, 2004 | ||||
Last Updated Date | October 29, 2008 | ||||
Start Date ICMJE | June 2004 | ||||
Current Primary Outcome Measures ICMJE |
To learn if RAD001 can shrink or slow the growth of tumors in patients who have recurrent endometrial cancer. [ Time Frame: 4 Years ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
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. [ Time Frame: 4 Years ] [ Designated as safety issue: No ] | ||||
Change History | Complete list of historical versions of study NCT00087685 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
The safety of this drug will also be studied. [ Time Frame: 4 Years ] [ Designated as safety issue: Yes ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Descriptive Information | |||||
Brief Title ICMJE | RAD001 in Recurrent Endometrial Cancer Patients | ||||
Official Title ICMJE | A Phase II Study of RAD001 in Patients With Recurrent Endometrial Cancer | ||||
Brief Summary | Primary Objective 1. To determine the efficacy of RAD001 in patients with progressive or recurrent endometrial cancer. Secondary Objective
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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. and . 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. |
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Study Phase | Phase II | ||||
Study Type ICMJE | Interventional | ||||
Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
Condition ICMJE | Endometrial Cancer | ||||
Intervention ICMJE | Drug: RAD001 | ||||
Study Arms / Comparison Groups | Experimental: RAD001 | ||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE | 35 | ||||
Completion Date | |||||
Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||
Ages | |||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID ICMJE | NCT00087685 | ||||
Responsible Party | Judith Wolf, MD/Associate Professor, U.T.M.D. Anderson Cancer Center | ||||
Study ID Numbers ICMJE | 2004-0002 | ||||
Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | M.D. Anderson Cancer Center | ||||
Verification Date | October 2008 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |