Trial Evaluating Feasibility and Quality of Life of Second Look Laparoscopy With Hyperthermic Intraperitoneal Chemotherapy

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this research study is to see if it is feasible to receive heated chemotherapy or heated intraperitoneal chemotherapy (HIPEC) inserted directly into the abdomen at the time of a Second Look Reassessment Surgery and to monitor any effects good or bad that this has on participants' health.

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

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboplatin

Criteria

Inclusion Criteria:

• Patients must have histologically I-III epithelial carcinoma of the ovary, fallopian tube or peritoneum or Stage IVA disease in which is there complete resolution of disease (pleural effusion) with chemotherapy

• Patients must have undergone cytoreductive surgery and 3-6 cycles of platinum-based systemic chemotherapy less than 12 weeks prior to the second look surgery. Systemic platinum based chemotherapy must be completed less than 12 weeks prior to second look surgery.

• Cytoreductive surgery must result in an R-0, R-1 resection prior to systemic chemotherapy

• The intraoperative peritoneal adhesion index should be < 10.[22] (See appendix)

• Patients must be without clinical evidence of disease including a negative exam, imaging (CT or PET/CT) and normal tumor markers (CA125) after completion of systemic chemotherapy.

• Age ≥ 18 years.

• ECOG performance status ≤ 2.

• Patients must have adequate organ and marrow function as defined below (within 30 days of registration): absolute neutrophil count >1,500/mcL; platelets >100,000/mcL; total bilirubin ≤ 1.5 mg/dL; creatinine clearance ≥ 50 mg/dL; AST(SGOT)/ALT(SGPT) ≤ 3X; institutional upper limit of normal; alkaline phosphatase 3X institutional upper limit of normal

• Adequate contraception and negative pregnancy test if pregnancy possible.

• Ability to understand and the willingness to sign an IRB-approved informed consent document.

Exclusion Criteria:

• Patients greater than 12 weeks from their last course of systemic platinum based chemotherapy

• Patients who have received additional chemotherapy for the ovarian cancer after primary therapy as outlined above.

• Patients may not have received prior abdominal or pelvic radiation.

• Extensive intra-abdominal adhesive disease noted at the time of initial cytoreductive surgery with PAI of >10 as defined above

• Intra-abdominal infection associated with initial cytoreductive surgery requiring extended hospitalization or related to systemic chemotherapy requiring hospitalization for therapy

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin.

• Uncontrolled intercurrent 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.

Pregnancy: Men are excluded from participation due to the site-specific nature of the disease being studied.