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Hyperthermic Intraperitoneal Chemotherapy for Recurrent Ovarian Cancer

Primary Purpose

Ovarian Cancer

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hyperthermic intraperitoneal chemotherapy (HIPEC)
Carboplatin
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Women's Cancer and Surgical Oncology CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HIPEC

Arm Description

A procedure in which the internal parts of your abdomen are bathed in a warm solution of anti-cancer medications for 90 minutes.

Outcomes

Primary Outcome Measures

Recurrence-free survival compared to historical controls
Surveillance CT Chest, abdomen and pelvis with IV and oral contrast and serum CA-125 levels will be obtained at 6 months after the day of surgery. Recurrence-free survival will be assessed using RECIST 1.1 guideline (version 1.1).
Recurrence-free survival compared to historical controls
Surveillance CT Chest, abdomen and pelvis with IV and oral contrast and serum CA-125 levels will be obtained at 9 months after the day of surgery. Recurrence-free survival will be assessed using RECIST 1.1 guideline (version 1.1).
Recurrence-free survival compared to historical controls
Surveillance CT Chest, abdomen and pelvis with IV and oral contrast and serum CA-125 levels will be obtained at 12 months after the day of surgery. Recurrence-free survival will be assessed using RECIST 1.1 guideline (version 1.1).
Recurrence-free survival compared to historical controls
Surveillance CT Chest, abdomen and pelvis with IV and oral contrast and serum CA-125 levels will be obtained at 18 months after the day of surgery. Recurrence-free survival will be assessed using RECIST 1.1 guideline (version 1.1).

Secondary Outcome Measures

Full Information

First Posted
January 27, 2016
Last Updated
May 8, 2023
Sponsor
Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT02672098
Brief Title
Hyperthermic Intraperitoneal Chemotherapy for Recurrent Ovarian Cancer
Official Title
Hyperthermic Intraperitoneal Chemotherapy for Recurrent Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2016 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
This is a phase I prospective study with the primary objective to compare the efficacy and safety of CRS and HIPEC. The target population for this study is patients with ovarian, primary peritoneal or fallopian tube cancers undergoing secondary CRS after the first platinum-sensitive recurrence. 'Platinum-sensitive' recurrence is defined as recurrence 6 months after the completion of the primary platinum-based chemotherapy. Carboplatin, delivered as HIPEC, will be administered at the time of surgery. Subjects will receive a single cycle of hyperthermic intraperitoneal chemotherapy. Patients will then go on to receive standard platinum-based combination doublet chemotherapy (carboplatin and paclitaxel, carboplatin and gemcitabine, or carboplatin and liposomal doxorubicin) for 6 cycles. 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 technique (43). 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. Surveillance CT Chest, abdomen and pelvis with IV and oral contrast and serum CA-125 levels will be obtained at 6, 9, 12 and 18 months after the day of surgery. Recurrence-free survival will be assessed using RECIST 1.1 guideline (version 1.1).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HIPEC
Arm Type
Experimental
Arm Description
A procedure in which the internal parts of your abdomen are bathed in a warm solution of anti-cancer medications for 90 minutes.
Intervention Type
Procedure
Intervention Name(s)
Hyperthermic intraperitoneal chemotherapy (HIPEC)
Other Intervention Name(s)
HIPEC
Intervention Description
Hyperthermic intraperitoneal chemotherapy (HIPEC) is a procedure in which the internal parts of the abdomen are bathed in a warm solution of anti-cancer medications for 90 minutes.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin, delivered as HIPEC, will be administered at the time of surgery. Subjects will receive a single cycle of hyperthermic intraperitoneal chemotherapy. a single dose of carboplatin (800 mg/m2) will be administered in normal saline via intraperitoneal hyperthermic perfusion using the closed-abdomen technique. HIPEC will be continued for 90 minutes in the hyperthermic phase (41°C-43°C).
Primary Outcome Measure Information:
Title
Recurrence-free survival compared to historical controls
Description
Surveillance CT Chest, abdomen and pelvis with IV and oral contrast and serum CA-125 levels will be obtained at 6 months after the day of surgery. Recurrence-free survival will be assessed using RECIST 1.1 guideline (version 1.1).
Time Frame
6 months after the day of surgery
Title
Recurrence-free survival compared to historical controls
Description
Surveillance CT Chest, abdomen and pelvis with IV and oral contrast and serum CA-125 levels will be obtained at 9 months after the day of surgery. Recurrence-free survival will be assessed using RECIST 1.1 guideline (version 1.1).
Time Frame
9 months after the day of surgery
Title
Recurrence-free survival compared to historical controls
Description
Surveillance CT Chest, abdomen and pelvis with IV and oral contrast and serum CA-125 levels will be obtained at 12 months after the day of surgery. Recurrence-free survival will be assessed using RECIST 1.1 guideline (version 1.1).
Time Frame
12 months after the day of surgery
Title
Recurrence-free survival compared to historical controls
Description
Surveillance CT Chest, abdomen and pelvis with IV and oral contrast and serum CA-125 levels will be obtained at 18 months after the day of surgery. Recurrence-free survival will be assessed using RECIST 1.1 guideline (version 1.1).
Time Frame
18 months after the day of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mazdak Momeni, MD
Phone
909-558-4000
Ext
15779
Email
mmomeni@llu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mazdak Momeni, MD
Organizational Affiliation
Loma Linda University Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women's Cancer and Surgical Oncology Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mazdak Momeni, MD
Phone
909-558-4000
Ext
15779
Email
mmomeni@llu.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16394300
Citation
Armstrong DK, Bundy B, Wenzel L, Huang HQ, Baergen R, Lele S, Copeland LJ, Walker JL, Burger RA; Gynecologic Oncology Group. Intraperitoneal cisplatin and paclitaxel in ovarian cancer. N Engl J Med. 2006 Jan 5;354(1):34-43. doi: 10.1056/NEJMoa052985.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/16394300/
Description
Intraperitoneal Cisplatin and Paclitaxel in Ovarian Cancer

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Hyperthermic Intraperitoneal Chemotherapy for Recurrent Ovarian Cancer

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