HIPEC After Initial CRS in Patients Who Have Received NACT

• Status: Recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

The majority of women diagnosed with ovarian, fallopian tube and primary peritoneal cancer present with advanced stage III and IV disease. Despite aggressive surgery and systemic chemotherapy, the majority of patients will relapse. Five year survival remains only 20-35% for patients diagnosed with bulky stage IIIC and IV cancers. Patients who are not candidates for an initial cytoreductive surgery at the time of diagnosis form a particularly poor prognosis group. These patients are treated with neoadjuvant chemotherapy (NACT) and will ultimately undergo cytoreductive surgery provided there is a response to chemotherapy. New therapies for this cohort of women are urgently needed.

The investigators have designed a pilot study to evaluate the feasibility of heated intraoperative peritoneal chemotherapy (HIPEC) given at the time of interval cytoreductive surgery after 3 cycles of NACT. Patients undergoing NACT for ovarian, fallopian tube or primary peritoneal cancer will be evaluated after their third cycle of chemotherapy for trial participation. Patient meeting eligibility criteria will proceed with cytoreductive surgery. HIPEC will be administered in those patients in whom optimal tumor cytoreduction is achieved. Primary objective of this study is to evaluate the feasibility, toxicity and tolerability of HIPEC administered after NACT.

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

Details

• Lead Sponsor: Northwell Health
• Collaborators: Katie Oppo Foundation; Katie Oppo Research Fund
• Treatments: Cisplatin

Criteria

Inclusion Criteria:

1. Histologically confirmed cancer of the ovary, fallopian tube or peritoneum.

2. Women of all races and ethnicities are eligible for this trial.

3. Age > 18.

4. The patient must have documented disease limited to the abdomen and pelvis that is amenable to complete CRS indicated by:

1. Disease confined to the peritoneal surfaces.

2. No clinical or radiological evidence of hematogenous or distant (extra-abdominal) nodal metastasis.

5. 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).

6. Gynecologic Oncology Group (GOG) performance status <= 2

7. Leukocytes >= 3,000/microliter (mcL), absolute neutrophil count >= 1,500/mcL, platelets >= 100,000/mcL

8. 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

9. Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min for patients with creatinine levels above institutional normal

10. Albumin >= 2.5 mg/dL

11. 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

12. Voluntary participation after getting written informed consent

Exclusion Criteria:

1. Prior chemotherapy (other than NACT) or whole abdomen radiation for ovarian, fallopian tube or primary peritoneal cancers.

2. Patients with an active second malignancy regardless of site.

3. 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

4. Pregnant or breast-feeding patients

5. Patients who are receiving other oncologic investigational therapeutic agents

6. 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).

7. Cardiac or pulmonary conditions that preclude aggressive cytoreductive surgery.

8. Patients found to have non-gynecologic cancer at the time of surgery.

9. Patients with gynecologic malignancy of low-grade serous or borderline histology.