Outcomes After Secondary Cytoreductive Surgery With or Without Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Followed by Systemic Combination Chemotherapy for Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Age ≥ 21 years old.

Patients with histologic diagnosis of epithelial ovarian carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma that has recurred \>6 months since platinum-based chemotherapy (first recurrence) and who are scheduled for secondary surgical evaluation/cytoreduction.

Histologic epithelial cell types include serous, endometrioid, clear cell, or undifferentiated carcinomas, transitional cell carcinoma, mixed epithelial carcinoma, malignant Brenner's tumor, or adenocarcinoma N.O.S.

Karnofsky Performance Status (KPS) of ≥ 70%.

Disease-free interval ≤ 30 months.

No prior chemotherapy in the recurrent setting. Prior hormonal therapy is permitted. Concomitant anti-neoplastic anti-hormonal therapy (including tamoxifen, aromatase inhibitors etc.) is not allowed for patients participating in study treatment. Low-dose (physiologic) estrogen hormone-replacement therapy (HRT) may be given.

Patients receiving maintenance biologic therapy are eligible, provided their recurrence is documented more than 6 months from completion of primary cytotoxic chemotherapy (includes maintenance chemotherapy) and a minimum of 3 weeks has elapsed since their last infusion of biologic therapy at the start of protocol intervention, day 1.

Patients must be, after evaluation by the investigator, appropriate candidates for the administration of 5 to 6 cycles of standard platinum-based combination chemotherapy (carboplatin and paclitaxel, carboplatin and liposomal doxorubicin, or carboplatin and gemcitabine) following CRS with or without HIPEC.

Bone marrow function:

Hemoglobin ≥ 8.5 g/dL.

Absolute neutrophil count (ANC) ≥ 1,000/mm3.

Platelets ≥ 100,000/mm3.

Renal function:

Creatinine ≤ 1.5mg/dl

Hepatic function:

Bilirubin ≤ 1.5 times ULN.

ALT ≤ 3 times the ULN.

AST ≤ 3 times the ULN.

Neurologic function:

Peripheral neuropathy ≤ CTC AE grade 2.

Blood coagulation parameters:

PT with an INR of ≤ 1.5 and a PTT ≤ 1.5 times the ULN. For patients on full-dose oral anti-coagulation (such as warfarin or rivaroxaban), in-range INR (usually between 2 and 3) and a PTT \<1.2 times the ULN.

Patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to CRS and must be practicing an effective form of contraception during the study period.

Patients will be consented prior to the surgical evaluation/cytoreductive surgery. Patients must have less than or equal to 0.5cm residual disease at the completion of the secondary surgery to be eligible for the study.

What this study is about