Hyperthermic Intraperitoneal Chemotherapy for Recurrent Ovarian Cancer

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase I prospective study with the primary objective to compare the efficacy and safety of Surgical cytoreduction (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in treatment of recurrent ovarian, primary peritoneal or fallopian tube cancers. Eligible patients consenting to this protocol will undergo their scheduled surgical procedure. After surgical cytoreduction to a residual disease ≤ 2.5 mm, a single dose of carboplatin (800 mg/m2) will be administered in normal saline via intraperitoneal hyperthermic perfusion using the closed-abdomen. HIPEC will be continued for 90 minutes in the hyperthermic phase (41°C-43°C). At 4-6 weeks after CRS, patients will go on to receive 6 cycles of standard IV platinum-based chemotherapy. The proportion of patients who are without evidence of recurrence will be assessed at 6, 9, 12 and 18 months after the day of surgery.

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

Details

• Lead Sponsor: Loma Linda University
• Treatments: Carboplatin

Criteria

Inclusion Criteria:

• Age > 21 years old • Patients with diagnosis of epithelial ovarian carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma that has recurred >6 months since platinum-based chemotherapy (first recurrence) and are scheduled for secondary surgical evaluation/cytoreduction • ECOG/WHO Performance score of 0 to 1

• Histologic types feature would be serous, endometrioid, clear cell, undifferentiated carcinomas, transitional cell carcinoma, or mixed epithelial carcinoma • No End organ function

• Patients must have less than or equal to 2.5 mm residual disease at the completion of the secondary surgery to be eligible for the study

Exclusion Criteria:

• Subjects who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded • Subjects with invasive malignancies or had any evidence of the other cancer present within the last 3 years

• Tumors of low malignant potential • Patients with active coronary artery disease • Patients with known acute hepatitis • Patients with restrictive or obstructive pulmonary disease

• Patient with extra-abdominal metastatic disease • Immuno-compromized patients

• Known carboplatin or Cisplatin allergy • Life expectancy < 3 months