Ovarian CancerPhase 1NCT02672098
Hyperthermic Intraperitoneal Chemotherapy for Recurrent Ovarian Cancer
A Phase 1 study testing Hyperthermic intraperitoneal chemotherapy (HIPEC) and Carboplatin in people with Ovarian Cancer, run by Loma Linda University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Hyperthermic intraperitoneal chemotherapy (HIPEC) and Carboplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2016to 19 Apr 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Women's Cancer and Surgical Oncology Center
Loma Linda, California, 92354
About this study
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.
Read the 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).
- Conditions
- Ovarian Cancer
- Being tested
- Hyperthermic intraperitoneal chemotherapy (HIPEC), Carboplatin
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperthermic intraperitoneal chemotherapy (HIPEC)Procedure or surgery
Also called 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.
CarboplatinDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| HIPEC | Experimental | A procedure in which the internal parts of your abdomen are bathed in a warm solution of anti-cancer medications for 90 minutes. Receives: Procedure: Hyperthermic intraperitoneal chemotherapy (HIPEC); Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months after the day of surgery
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).
Measured: 9 months after the day of surgery
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).
Measured: 12 months after the day of surgery
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).
Measured: 18 months after the day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study start14 Jul 2016
- Primary completion19 Apr 2023
- Study completion19 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mazdak Momeni, MD, Principal investigator, Loma Linda University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02672098
- Sponsor's protocol ID
- 5150302
- Status last verified
- May 2025
- First submitted
- 27 Jan 2016
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 16394300
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperthermic Intraperitoneal Chemotherapy for Recurrent Ovarian Cancer
- ClinicalTrials.gov ID
- NCT02672098
- Acronym / sponsor ID
- 5150302
- Conditions
- Ovarian Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 14 Jul 2016 (actual)
- Primary completion
- 19 Apr 2023 (actual)
- Study completion
- 19 Apr 2023 (actual)
- First posted
- 3 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIPEC | Experimental | Procedure: Hyperthermic intraperitoneal chemotherapy (HIPEC), Drug: CarboplatinA procedure in which the internal parts of your abdomen are bathed in a warm solution of anti-cancer medications for 90 minutes. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperthermic intraperitoneal chemotherapy (HIPEC)Also: HIPECHyperthermic 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. | Procedure or surgery | HIPEC |
| CarboplatinCarboplatin, 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). | Drug | HIPEC |
Primary outcome
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).
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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Results publication: PubMed 16394300Armstrong 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.
- Intraperitoneal Cisplatin and Paclitaxel in Ovarian CancerLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Ovarian Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mazdak Momeni, MD principal investigator
Loma Linda University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hyperthermic intraperitoneal chemotherapy (HIPEC) and Carboplatin in people with Ovarian Cancer, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival compared to historical controls (time frame: 6 months after the day of surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02672098, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.