Uterine Serous Carcinoma and Adjuvant Combined Intraperitoneal Chemotherapy and Radiation

• Status: Not yet recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

Uterine serous carcinoma (USC) is an uncommon, but aggressive variant of endometrial carcinoma that has poor response to standard therapy. After staging and surgery, radiation therapy and/or chemotherapy is recommended to treat patients at high risk for recurrence. In advanced stage and recurrent setting, high risk uterine cancer mirrors ovarian cancer with it spread patterns and response to therapy. Based on these findings and the similarities as well as the clinical success of paclitaxel with IP platinum therapy in patients with ovarian serous carcinoma, investigators propose to prospectively assess IV/IP therapy in patients with advanced stage and recurrent USC.

During Week 1-18, subjects will be placed on open-label IP Carboplatin/IV Paclitaxel on Day 1, then administered IP Paclitaxel on Day 8. This will be repeated every 3 weeks for 6 cycles. A CT imaging scan will be performed after six cycles of chemotherapy, prior to radiation. Also, in Week 19-23, subjects will receive Pelvic radiation therapy (IMRT) if deemed necessary. Additionally, from Week 24-26, High Dose Radiation or IMRT will be used where appropriate.

Patients will be monitored for toxicity and feasibility of the regimen. Secondary outcomes will include assessing the frequency and the reasons for early discontinuation of the study treatments as well as describing patient-reported quality of life parameters at specified time points during the study using validated questionnaires: EORTC QLQ-C30 and QLQ-OV28.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwell Health
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

Criteria

Inclusion Criteria:

1. Histological/cytologically documented primary FIGO Stage IIIA, IIIB, IIIC1, IIIC2, IVA and IVB uterine serous carcinoma. Patients with stage IVB disease include abdominal sites of metastasis only.

2. All patients must have a procedure for determining the definitive diagnosis of USC. At the discretion of the surgeon, complete surgical staging should include: total hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, omental biopsy and lymph node evaluation.

3. Residual disease at completion of surgery of ≤ 1cm by surgeon report.

4. Age > 18 years.

5. ECOG performance status of ≤ 2.

6. Written voluntary informed consent.

Exclusion Criteria:

1. Distant metastasis outside the abdominal cavity.

2. Patient has impairment of hepatic, renal or hematologic function as defined by the following baseline laboratory values:

1. Serum SGOT and /or SGPT > 2.5 times the institutional upper limit of normal (ULN)

2. Total serum bilirubin > 1.5 mg/dl

3. Serum creatinine > 2.0 mg/dl

4. Platelets < 100,000/mm3

5. Absolute neutrophil count (ANC) < 1500/mm3

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

3. History of abdominal/pelvic radiation therapy.

4. Severe or uncontrolled, concurrent medical disease (e.g. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.)

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