A Phase II Study: Paclitaxel and Pelvic Radiation for Stage I-IIIA Papillary Serous Carcinoma of the Endometrium
Paclitaxel is designed to block the mechanisms of cell division in cancer cells, which may
cause them to die.
Before you can start treatment on this study, you will have "screening tests." These tests
will help the doctor decide if you are eligible to take part in this study. You will have a
complete physical exam, including measurement of your height, weight, and body surface area.
Your complete medical history will be recorded. Your cancer diagnosis will be confirmed by
checking tissue slides from the tissue removed during yoru surgery. You will have blood
drawn (about 1 tablespoon) for routine tests, tests of your liver function, and CA-125
levels. You will also have chest x-rays, a computed tomography (CT) scan of your chest, and
either a CT or magnetic resonance imaging (MRI) scan of your abdomen and pelvis. These
scans should be performed within 6 weeks before starting study treatment.
If you are found to be eligible to take part in this study, you will begin treatment. You
will have radiation treatment to your pelvis (hip area) every day (Monday - Friday) for a
total of 25 treatments. Each treatment should take about 20 minutes to complete.
After the radiation treatment, you will receive a type of radiation called a "vaginal cuff
boost." The vaginal cuff boost involves a small device being inserted into the vagina to
treat the back of the vagina with a high dose of radiation. The applicator is similar to
placing a large tampon in the vagina. This internal treatment takes about 30 minutes for
each treatment. This is separate from the external radiation treatments that are given.
While you are receiving radiation treatment, and then afterwards, you will also receive
chemotherapy with paclitaxel. During the radiation period, you will receive paclitaxel by
vein over 1 hour, on Days 1, 8, 15, 22, and 29. Starting 4-6 weeks after radiation
treatment is finished, you will receive paclitaxel at a larger dose, given over 3 hours each
time, once every 21 days (3 weeks). You will receive up to 4 "cycles" of chemotherapy, each
cycle lasting 21 days.
You will be given certain drugs about 30 minutes before your chemotherapy treatments to help
control possible side effects, like allergic reactions. These drugs include dexamethasone,
diphenhydramine (Benadryl), and cimetidine.
You will have several tests performed throughout the study. Before each cycle of
chemotherapy and one month after the last cycle of chemotherapy is given, quality of life
and symptom assessment forms will be completed. These questionnaires should only take about
15 minutes to complete.
While you are on chemotherapy treatment, you will have tests performed before each
chemotherapy treatment. This will involve blood (about 1 tablespoon) drawn for routine
tests, and a review of your symptoms by the study staff.
Once you are off study treatment, you will be asked to return to the clinic for follow-up
visits. These visits will occur every 3 months for 1 year, then every 4 months for 2 years,
then every 6 months for 2 years, then once a year after that. At these visits, you will
have a physical and pelvic exam performed, along with blood (about 1 tablespoon) drawn for
routine tests. Chest x-rays will usually be done once a year and any other diagnostic exams
will only be done if your doctor thinks they are needed.
This is an investigational study. There are no standard treatments for this type of
endometrial cancer, but radiation and chemotherapy are common treatments. This combination
of chemotherapy and radiation is considered experimental. Up to 49 patients will take part
in this multicenter study. Up to 44 participants will be enrolled at M. D. Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Continual Assessments (every 3 months for 1 year, then every 4 months for 2 years, then every 6 months for 2 years, then once a year)
Anuja Jhingran, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|
|M. D. Anderson Cancer Center - Orlando||Orlando, Florida 32806|