A Phase II Study of Adjuvant Postoperative Radiation With Cisplatin Followed by Carboplatin/Paclitaxel Chemotherapy Following Total Abdominal Hysterectomy/Bilateral Salpino-Oophorectomy (TAH/BSO) for Patients With Stage I, II and IIIa Malignant Mixed Mesodermal Tumor (MMMT) of the Uterus.
Patients in this study will have an operation to remove their uterus, tubes, and ovaries
with biopsies of the omentum and lymph nodes before entering this study.
Before treatment starts, patients will have a chest x-ray, computed tomography (CT) scan,
blood tests, and a physical exam. Patients who have a history of hearing loss will have a
Within 8 weeks after surgery, patients will receive 5 weeks of combination radiation therapy
and cisplatin chemotherapy. Radiation and cisplatin will be given on Day 1 or day 2 of each
week followed by 4 days of radiation alone. An additional dose of radiation, directed at
the surface of the vagina, will be given either during the last week (Week 5) of treatment
or after the radiation and cisplatin chemotherapy is finished.
Three to five weeks after radiation therapy and cisplatin chemotherapy is finished, patients
will receive additional chemotherapy. Carboplatin and paclitaxel will be given every 28 days
for 4 cycles. All chemotherapy is given into the vein through a catheter (tube).
Patients will be taken off study if their disease gets worse or intolerable side effects
occur. Patients will be seen one month after the last cycle of chemotherapy, then every 3-4
months from then on for 2 years. At each visit, patients will have blood tests and a
physical exam. Computed tomography (CT) scans will be ordered only if it is suspected that
the disease has come back. All patients will be followed for a maximum of 2 years after
their therapy is completed.
This is an investigational study. Cisplatin, Carboplatin and Paclitaxel are FDA approved
and commercially available. A total of 49 patients will take part in this study. Up to 25
patients may be enrolled at M. D. Anderson Cancer Center in Houston, up to 12 patients will
be enrolled at MD Anderson Cancer Center, Orlando, and up to 12 patients will be enrolled at
the University of Texas Medical Branch in Galveston.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Survival defined as observed length of life from study entry until death or, for living patients, date of last contact.
Lois M. Ramondetta, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|University of Washington School of Medicine||Seattle, Washington 98195|
|UT MD Anderson Cancer Center||Houston, Texas 77030|