Paclitaxel and Intraperitoneal Carboplatin Followed by Radiation Therapy in Treating Patients With Stage IIIC-IV Uterine Cancer

• Status: Terminated
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albert Einstein College of Medicine; Albert Einstein College of Medicine of Yeshiva University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

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