Participate in Research at CU Anschutz

Patients will be registered prior to, during or at the completion of neoadjuvant chemotherapy (Paclitaxel 175 mg/m2 IV over 3 hours and Carboplatin AUC 6 IV on Day 1 every 21 days for 3-4 cycles). Registered patients who progress during neoadjuvant chemotherapy will not be eligible for iCRS and will be removed from the study. Following completion of neoadjuvant chemotherapy, interval cytoreductive surgery (iCRS) will be performed in the usual fashion in both arms. Patients will be randomized at the time of iCRS (iCRS must achieve no gross residual disease or no disease >1.0 cm in largest diameter) to receive HIPEC or no HIPEC. Patients randomized to HIPEC (Arm A) will receive a single dose of cisplatin (100mg/m2 IP over 90 minutes at 42 C) as HIPEC. After postoperative recovery patients will receive standard post-operative platinum-based combination chemotherapy. Patients randomized to surgery only (Arm B) will receive postoperative standard chemotherapy after recovery from surgery. Both groups will receive an additional 2-3 cycles of platinum-based combination chemotherapy per institutional standard (Paclitaxel 175 mg/m2 IV over 3 hours and Carboplatin AUC 6 IV on Day 1 every 21 days for 2-3 cycles) for a maximum total of 6 cycles of chemotherapy (neoadjuvant plus post-operative cycles) followed by niraparib individualized dosing until progression or 36 months (if no evidence of disease).

This study plans to learn more about if giving heated chemotherapy into the belly, known as heated intraperitoneal chemotherapy (HIPEC), improves the treatment of your type of cancer. You are being asked to be in this research study because you have newly diagnosed ovarian, primary peritoneal or fallopian tube cancer that will be treated with chemotherapy and surgery. The goal of HIPEC is to expose any cancer left in the belly after surgery to high doses of chemotherapy. The chemotherapy is heated in the hope that this will make it easier for it to get into and kill the cancer cells. The drug used for HIPEC will be cisplatin, a Food and Drug Administration (FDA) approved drug for use in ovarian, fallopian tube or primary peritoneal cancer, although it has not specifically been approved for use for HIPEC. There are several studies that have looked at the use of HIPEC for your type of cancer. However, in these studies, physicians selected which patients would receive HIPEC treatment instead of patients being randomized to HIPEC treatment. Because of this, the results of these studies are not definitive enough to say if HIPEC is effective. The use of HIPEC using cisplatin in this study is being investigated to determine if it improves your cancer. This study will compare treatment with HIPEC with cisplatin during surgery to surgery alone to see if patients who receive HIPEC have an improvement in their cancer. Your doctor has decided that you are a candidate for surgery. If you agree to take part in this study, at the time of your surgery you will be randomized by a computer to one of two groups. It is similar to flipping a coin. The first group will receive (or will have received) neoadjuvant chemotherapy with paclitaxel/docetaxel/Nab-paclitaxel and carboplatin. They will then undergo surgery then receive HIPEC at the time of surgery, followed by standard chemotherapy with paclitaxel/docetaxel/Nab-paclitaxel and carboplatin, then maintenance treatment with niraparib. The HIPEC will contain cisplatin that is given directly into the belly at the end of your surgery when you are still under anesthesia. If you are assigned to HIPEC, it will add about 120-150 minutes (2-2.5 hours) to the procedure time. The second group will receive (or will have received) neoadjuvant chemotherapy with paclitaxel/docetaxel/Nab-paclitaxel and carboplatin. They will then undergo surgery followed by standard postoperative chemotherapy with paclitaxel/docetaxel/Nab-paclitaxel and carboplatin, followed by maintenance treatment with niraparib. The goal of maintenance therapy with niraparib is to prevent or delay your cancer from returning. During the postoperative follow up we will check whether your cancer has come back or not. Ultimately, we want to see which treatment is more effective at preventing your cancer from coming back and to find out the side effects of both treatments. The chemotherapy drugs paclitaxel, docetaxel, Nab-paclitaxel and carboplatin and the drug niraparib are FDA-approved drugs. Paclitaxel when used with cisplatin and carboplatin are approved for use in your type of cancer.