Paclitaxel and Intraperitoneal Carboplatin Followed by Radiation Therapy in Treating Patients With Stage IIIC-IV Uterine Cancer
Condition: Endometrial Serous Adenocarcinoma; Stage IIIA Uterine Corpus Cancer; Stage IIIB Uterine Corpus Cancer; Stage IIIC1 Uterine Corpus Cancer; Stage IIIC2 Uterine Corpus Cancer; Stage IVA Uterine Corpus Cancer; Stage IVB Uterine Corpus Cancer
MeSH terms: Cystadenocarcinoma, Serous
Intervention: Paclitaxel; Carboplatin; 3-Dimensional Conformal Radiation Therapy; Intensity-Modulated Radiation Therapy; Quality-of-Life Assessment; Laboratory Biomarker Analysis
Intervention description: Given IV; Given IP; Undergo 3D conformal radiation therapy; Undergo IMRT; Ancillary studies; 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: 4.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This pilot, phase II trial studies the side effects and how well paclitaxel given into the
      vein and carboplatin given directly into the abdominal cavity (intraperitoneally) followed by
      radiation therapy work in treating patients with stage IIIC-IV serous uterine cancer. 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, stopping them from dividing, or stopping
      them from spreading. Giving the drugs in different ways may kill more tumor cells. Radiation
      therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy followed by
      radiation therapy may be an effective treatment for uterine cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological/cytologically documented primary International Federation of Gynecology
             and Obstetrics (FIGO) stage 3C1, 3C2, stage 4A, and 4B uterine serous carcinoma; in
             addition, certain stage 3A and B disease are also allowed

               -  Residual disease after primary surgery:

                    -  Eligible:

                         -  Stage 3A and B (pelvic, but confined to adnexa or vagina), residual
                            disease present

                         -  Stage 3CI (pelvic node positive)

                         -  Stage 3CII (para-aortic node positive)

                         -  Stage 4A (bladder or pelvic bowel)

                         -  Stage 4B (distant metastases [mets] including abdominal mets),
                            completely resected

                    -  Not eligible

                         -  Stage 3A and B (pelvic, but confined to adnexa or vagina), completely
                            resected

                         -  Stage 4B (distant mets including abdominal mets), residual disease
                            present

          -  All patients must have a procedure for determining diagnosis of high-risk uterine
             cancer (HRUC); minimum surgical intervention required is tissue biopsy (may be from
             endometrium), if significant clinical evidence exists to support a stage 3 or 4
             diagnosis; as per the discretion of the surgeon, complete surgical staging should
             include: total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal
             washings, omental biopsy and lymph node samplings; this is typically the standard
             unless the disease is bulky or the clinician feels the patient would be best served by
             chemotherapy and radiation therapy after histologic diagnosis is confirmed

          -  Eastern Cooperative Oncology Group (ECOG) performance status of =< 2

          -  Written voluntary informed consent

        Exclusion Criteria:

          -  Distant metastasis to the lung, bone or brain; typically, most stage 4 uterine
             papillary serous cancer (UPSC) is confined to the abdomen on presentation

          -  Serum glutamic oxaloacetic transaminase (SGOT) and/or serum glutamate pyruvate
             transaminase (SGPT) > 2.5 times the institutional upper limit of normal (ULN)

          -  Total serum bilirubin > 1.5 mg/dl

          -  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)

          -  History of abdominal/pelvic radiation therapy

          -  Severe or uncontrolled, concurrent medical disease (e.g. uncontrolled diabetes,
             unstable angina, myocardial infarction within 6 months, congestive heart failure,
             etc.)

          -  Patients with dementia or altered mental status that would prohibit the giving and
             understanding of informed consent at the time of study entry