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A Phase II Study: Paclitaxel and Pelvic Radiation for Stage I-IIIA Papillary Serous Carcinoma of the Endometrium

Phase 2
Not Enrolling
Endometrial Cancer

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Trial Information

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.

Inclusion Criteria:

1. Patient must undergo surgical staging within 8 weeks of study entry.

2. Patients with mixed histology tumor that include a papillary serous component are

3. Only patients with non-measurable disease can be entered.

4. Patients may not have had previous chemotherapy or radiation therapy.

5. Patients must have an estimated life expectancy of 12 weeks or greater.

6. Patients must have a Zubrod performance status of less than or equal to 2.

7. Patients must have adequate bone marrow, renal and hepatic function: with WBC greater
than or equal to 3000; ANC greater than or equal to 1500; Platelets greater than or
equal to 100,000; SGPT less than or equal to 2x the upper limit of normal; Total
bilirubin less than or equal to 2.5mg/dl.

8. Patients must sign an institutionally approved consent form

Exclusion Criteria:

1. Previously treated papillary serous carcinoma with either chemotherapy or radiation

2. Newly diagnosed papillary serous carcinoma of the endometrium, Stage IIIB-IV
(patients with disease outside the pelvis).

3. Patients who have a history of other malignancy, with the exception of
non-melanomatous skin cancer, unless in complete remission and off all therapy for
that disease for a minimum of 5 years.

4. Patients with a Zubrod status of 3 or greater.

5. Patients with an active infection.

6. Patients with serious intercurrent medical illness.

7. Patients with a recent (within 6 months) history of congestive heart failure,
unstable angina or myocardial infarction.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

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)

Safety Issue:


Principal Investigator

Anuja Jhingran, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

April 2001

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • Endometrial Cancer
  • Papillary Serous Carcinoma
  • Pelvic Radiation Therapy
  • Paclitaxel
  • Taxol
  • Carcinoma
  • Endometrial Neoplasms
  • Cystadenocarcinoma, Serous
  • Adenoma



UT MD Anderson Cancer Center Houston, Texas  77030
M. D. Anderson Cancer Center - Orlando Orlando, Florida  32806