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Hyperthermic Intraperitoneal Chemotherapy for Recurrent Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT02672098
Recruitment Status : Recruiting
First Posted : February 3, 2016
Last Update Posted : September 27, 2017
Sponsor:
Information provided by (Responsible Party):
Loma Linda University

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Procedure: Hyperthermic intraperitoneal chemotherapy (HIPEC) Drug: Carboplatin Phase 1

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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hyperthermic Intraperitoneal Chemotherapy for Recurrent Ovarian Cancer
Actual Study Start Date : July 14, 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018


Arm Intervention/treatment
Experimental: HIPEC
A procedure in which the internal parts of your abdomen are bathed in a warm solution of anti-cancer medications for 90 minutes.
Procedure: Hyperthermic intraperitoneal chemotherapy (HIPEC)
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.
Other Name: HIPEC

Drug: Carboplatin

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 Measures :
  1. Recurrence-free survival compared to historical controls [ Time Frame: 6 months after the day of surgery ]
    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).

  2. Recurrence-free survival compared to historical controls [ Time Frame: 9 months after the day of surgery ]
    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).

  3. Recurrence-free survival compared to historical controls [ Time Frame: 12 months after the day of surgery ]
    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).

  4. Recurrence-free survival compared to historical controls [ Time Frame: 18 months after the day of surgery ]
    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).



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672098


Contacts
Contact: Mazdak Momeni, MD 909-558-4000 ext 15779 mmomeni@llu.edu

Locations
United States, California
Women's Cancer and Surgical Oncology Center Recruiting
Loma Linda, California, United States, 92354
Contact: Mazdak Momeni, MD    909-558-4000 ext 15779    mmomeni@llu.edu   
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Mazdak Momeni, MD Loma Linda University Cancer Center

Additional Information:
Publications of Results:
Responsible Party: Loma Linda University
ClinicalTrials.gov Identifier: NCT02672098     History of Changes
Other Study ID Numbers: 5150302
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Fever
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Body Temperature Changes
Signs and Symptoms
Carboplatin
Antineoplastic Agents