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Enzalutamide for Uterine Cancer
Study Summary
This trial is testing a combination of drugs to treat endometrioid endometrial cancer.
- Uterine Corpus Cancer
- Uterine Cancer
- Endometrial Adenocarcinoma
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You have had an allergic reaction to medications similar to enzalutamide, carboplatin, or paclitaxel.You are able to perform daily activities without significant help or limitations due to your health condition.You should not have any active infections requiring antibiotics, except for a simple urinary tract infection.Your doctor thinks you are likely to live for at least three more months. You have recovered from any recent surgeries, radiation therapy, or chemotherapy.You are able to swallow pills without crushing or breaking them.You have a recurrence of cancer that can be treated with radiation therapy or surgery.Any treatment for your cancer, including immunotherapy, must be stopped at least three weeks before joining the study.You have a sufficient number of a type of white blood cells called neutrophils, which is measured by a blood test.You have been diagnosed with endometrioid endometrial cancer that has advanced to stage III or IV, or has come back after previous treatment.You must have a lesion that can be measured using imaging tests like CT scans or MRIs. The lesion must be at least 10 mm in size, or 20 mm if measured by chest x-ray. Lymph nodes must be at least 15 mm in size when measured on CT or MRI.You must have a visible tumor that will be measured to see if the treatment is effective. If you previously had radiation therapy, any tumors within that area will not be measured unless they continue to grow or persist after 90 days.If you are taking any hormonal therapy for your cancer, you must stop taking it at least one week before starting the study.You have not received chemotherapy for advanced or recurrent endometrial cancer. If you were given chemotherapy along with radiation therapy as a radiosensitizer, you are still eligible to participate.You have not fully recovered from recent surgery, radiation therapy, or chemotherapy.You cannot take any other cancer treatments or experimental drugs for at least three weeks before starting this study. You also cannot take any experimental drugs while participating in this study.You have had seizures in the past or have a history of brain injury, stroke, or abnormal blood vessels in the brain that can increase the risk of seizures.
- Group 1: Treatment (enzalutamide, paclitaxel, carboplatin)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What are the benefits of Enzalutamide?
"Enzalutamide is often used to treat castration, but can also be helpful for patients with advanced endometrial cancer, melanoma, and neoplasm metastasis."
Is there a high risk of negative side effects from Enzalutamide?
"While there is some evidence of safety, as this is a Phase 2 trial, none of the data collected thus far supports efficacy. Power has given Enzalutamide a score of 2."
Are there any limits to the amount of people who can join this clinical trial?
"As of now, this clinical trial is not admitting any more patients. This specific study was created on August 24th, 2016 and updated November 2nd, 2021. If you are interested in other trials, there are 1356 for endometrial neoplasms and 1327 for Enzalutamide that are currently active."
What other research projects have used Enzalutamide in the past?
"There are a total of 1327 clinical trials currently being conducted that involve Enzalutamide. Out of those, 372 have reached Phase 3. The primary locations for these trials are in Shanghai but there are 72676 different hospitals and research centres running these trials globally."
How many clinical sites are participating in this trial?
"There are 6 hospitals where this study is enrolling patients. They are based in The Woodlands, Houston and Sugar Land as well as 3 other locations. To make the process more convenient for you, consider enrolling at the site which is closest to your home."
Are people with the required medical condition able to participate in this trial at this time?
"As of right now, this particular trial is not looking for any more patients. This information can be found by looking at the date of the last update, which was on November 2nd, 2021. If you are interested in other trials, there are 1356 active studies enrolling patients with endometrial neoplasms and 1327 studies actively recruiting participants for Enzalutamide research."
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