Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Endometrial Cancer
Condition: Endometrial Adenocarcinoma; Stage IA Uterine Corpus Cancer; Stage IB Uterine Corpus Cancer; Stage II Uterine Corpus Cancer; Stage IIIA Uterine Corpus Cancer; Stage IIIB Uterine Corpus Cancer; Stage IIIC Uterine Corpus Cancer; Stage IVA Uterine Corpus Cancer; Stage IVB Uterine Corpus Cancer
MeSH terms: Endometrial Neoplasms
Intervention: Paclitaxel; Carboplatin; Internal Radiation Therapy; External Beam Radiation Therapy; Laboratory Biomarker Analysis
Intervention description: Given IV; Given IV; Undergo HDR brachytherapy; Undergo EBRT; Correlative studies
Intervention MeSH terms: Paclitaxel; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well radiation therapy, paclitaxel, and carboplatin work in
      treating patients with high-risk endometrial cancer. Radiation therapy uses high energy x
      rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin,
      work in different ways to stop the growth of tumor cells, either by killing the cells, by
      stopping them from dividing or by stopping them from spreading. Giving radiation therapy with
      chemotherapy may kill more tumor cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically-documented high-risk endometrioid adenocarcinoma with no visible
             residual disease, defined by the following criteria:

               -  Surgical stage I disease with < 50 myometrial invasion and grade 3 tumor (IAG3)
                  with lymphovascular space involvement;

               -  Surgical stage I disease with >= 50% myometrial invasion and grade 2 or 3 tumor
                  (IBG2, IBG3);

               -  Any surgical stage II disease (II);

               -  Any surgical stage III disease (IIIA, IIIB, IIIC); and

               -  Any surgical stage IV disease with no residual macroscopic tumor

          -  Surgical staging to include total abdominal hysterectomy, bilateral
             salpingo-oophorectomy, peritoneal washings, and lymph node samplings as per standard
             Gynecologic Oncology Group (GOG) criteria

          -  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/mm^3

          -  Absolute neutrophil count (ANC) < 1500/mm^3

          -  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 dementia or altered mental status that would prohibit the giving and
             understanding of informed consent at the time of study entry

          -  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