Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With Uterine Cancer

PRIMARY OBJECTIVES:

I. To assess the one year recurrence-free survival in patients with uterine carcinosarcoma
treated with "sandwich" therapy-including defining the patterns of recurrence in patients
with carcinosarcoma who were treated with this regimen.

II. To evaluate the toxicity and tolerability of pelvic radiation "sandwiched" between
cycles of paclitaxel/carboplatin chemotherapy in patients with uterine carcinosarcoma.

III. To correlate surrogate endpoint biomarkers with progression-free survival and
prognosis.

OUTLINE:

CHEMOTHERAPY (weeks 1-9, 14-22): Patients receive paclitaxel intravenously (IV) over 3 hours
and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses
during weeks 1-9 and 14-22.

RADIATION THERAPY (weeks 8-16): Patients undergo external beam pelvic radiation therapy once
a day, 5 days a week for 5 weeks during weeks 8-13. Patients then undergo high dose
radiation (HDR) brachytherapy or intensity-modulated radiation therapy (IMRT) once weekly
during weeks 14-16.

After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 3 years, and then annually thereafter.

Inclusion Criteria:

- Histologically documented uterine carcinosarcoma with no visible residual disease

- Surgical staging to include total abdominal hysterectomy, bilateral
salpingo-oophorectomy, peritoneal washings, and lymph node samplings

- Patients must be entered no more than 12 weeks post operatively

- Eastern Cooperative Oncology Group (ECOG) performance status of < 2

- Written voluntary informed consent

Exclusion Criteria:

- Serum glutamic oxaloacetic transaminase (SGOT) and /or serum glutamate pyruvate
transaminase (SGPT) > 2.5 times the institutional upper limit of normal

- Total serum bilirubin > 1.5 mg/dl

- History of chronic or active hepatitis

- Serum creatinine > 2.0 mg/dl

- Platelets < 100,000/mm3

- Absolute neutrophil count (ANC) < 1500/mm3

- Hemoglobin < 8.0 g/dl (the patient may be transfused prior to study entry)

- Patient has severe or uncontrolled concurrent medical disease (e.g. uncontrolled
diabetes, unstable angina, myocardial infarction within 6 months, congestive heart
failure, etc.)

- Patient with any prior chemotherapy or radiotherapy for pelvic malignancy

- Patients with any history of cancer with the exception of non-melanoma skin cancer
are excluded if there is any evidence of other malignancy being present within the
past five years

- Patients with dementia or altered mental status that would prohibit the giving and
understanding of informed consent at the time of study entry