HIPEC After Initial CRS in Patients Who Have Received NACT
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed cancer of the ovary, fallopian tube or peritoneum.
- Women of all races and ethnicities are eligible for this trial.
- Age > 18.
The patient must have documented disease limited to the abdomen and pelvis that is amenable to complete CRS indicated by:
- Disease confined to the peritoneal surfaces.
- No clinical or radiological evidence of hematogenous or distant (extra-abdominal) nodal metastasis.
- Evidence of response to NACT must as documented by at least one of the following: decline in serum CA125 level, at least a 30% decrease in the sum of the longest diameter of target lesions on radiographic imaging, or resolution of ascites or pleural effusion(s).
- Gynecologic Oncology Group (GOG) performance status <= 2
- Leukocytes >= 3,000/microliter (mcL), absolute neutrophil count >= 1,500/mcL, platelets >= 100,000/mcL
- Adequate hepatic function as measured by total bilirubin within normal institutional limits, aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase (SGOT))/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase (SGPT)) =< 2.5 x institutional upper limit of normal
- Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min for patients with creatinine levels above institutional normal
- Albumin >= 2.5 mg/dL
- Satisfactory cardiopulmonary function (no history of severe congestive heart failure or severe pulmonary disease, as indicated by clinically acceptable risks to undergo major abdominal surgery
- Voluntary participation after getting written informed consent
Exclusion Criteria:
- Prior chemotherapy (other than NACT) or whole abdomen radiation for ovarian, fallopian tube or primary peritoneal cancers.
- Patients with an active second malignancy regardless of site.
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or breast-feeding patients
- Patients who are receiving other oncologic investigational therapeutic agents
- Patients receiving NACT whose disease has progressed following at least 3 cycles of platinum-based therapy, defined by at least one of the following: clinical deterioration (new or worsening of existing ascites, carcinomatous ileus, malignant bowel obstruction, declining performance status); new lesion(s) or increase in maximal diameter of > 20% of the two largest target lesions; rising CA-125 (an increase of at least 10% of baseline value that increases over 3 values obtained every 21 days).
- Cardiac or pulmonary conditions that preclude aggressive cytoreductive surgery.
- Patients found to have non-gynecologic cancer at the time of surgery.
- Patients with gynecologic malignancy of low-grade serous or borderline histology.
Sites / Locations
- Long Island Jewish Medical CenterRecruiting
Arms of the Study
Arm 1
Experimental
HIPEC
Patient will receive HIPEC in the form of Cisplatin 100mg/m2. 5. HIPEC will be provided at completion of surgical cytoreduction. The chemotherapy will be ordered by the treating gynecologic oncologist. It will be prepared in the chemotherapy pharmacy and delivered to the operating room once the surgeon confirms optimal cytoreduction and eligibility. Patients undergoing bowel resection will be left with bowel in discontinuity during the HIPEC infusion cycle. The abdomen will be temporarily closed with skin staples to prevent spillage of the perfusate. HIPEC will be delivered using the closed technique as has been well described.