Ovarian CancerPhase 2NCT03321188
Heated Intraperitoneal Chemotherapy in Primary Ovarian Cancer Patients
A Phase 2 study testing HIPEC, Carboplatin and Paclitaxel in people with Ovarian Cancer and Epithelial Ovarian Cancer, run by Andrea Jewell at 1 site in United States.
Trial summary
This study will evaluate the use of Heated Intraperitoneal Chemotherapy (HIPEC) for primary treatment of ovarian cancer at the time of surgical debulking, to assess if intravenous (IV) chemotherapy can be started within 42 days of HIPEC and cytoreduction. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Epithelial Ovarian Cancer, Fallopian Tube Cancer
- What is being tested?
- HIPEC, Carboplatin and Paclitaxel
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2017to 15 Dec 2024
- Phase
- Phase 2
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and the willingness to sign a written informed consent.
- Patients with a histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, Stage 3(III)B - 3(III)C with optimal (≤ 1 centimeter) residual disease.
- Patients with the following histologic epithelial cell types are eligible:
- Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified.
- No previous HIPEC.
- Patient has a planned cytoreduction surgery - Note: registration occurs during surgery and not before; if, during surgery, the Principal Investigator/Sub-Investigator discerns that all disease cannot be removed surgically, the participant will be considered a "screen failure", HIPEC will not be performed, and the participant will be removed from the study.
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- Age ≥ 18 years.
- Performance Status Eastern Cooperative Group (ECOG) 0- 2
- Adequate organ and marrow function as defined below:
- absolute neutrophil count ≥ 1.5 kilograms per microliter (K/UL)
- platelets ≥ 100 K / UL
- total bilirubin within 1.5 x normal institutional limits
- Aspartate Aminotransferase (AST) / Serum Glutamic Oxaloacetic Transaminase (SGOT) ≤ 2.5 X institutional upper limit of normal
- Alanine Aminotransferase (ALT) / Serum Glutamic Pyruvic Transaminase (SPGT) ≤ 2.5 X institutional upper limit of normal
- creatinine within 1.5 x normal institutional limits
- Note: If a potential participant has non-clinically significant variances related to the organ and marrow parameters listed above, PI review and approval is required before enrollment.
- Women of child-bearing potential and their male partners also of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; OR Has not been naturally postmenopausal for at least 12 consecutive months (has had menses at any time in the preceding 12 consecutive months)
- Note: Acceptable forms of birth control are listed below:
- One Barrier method (cervical cap with spermicide plus male condom; diaphragm with spermicide plus male condom) Plus Hormonal method (oral contraceptives, implants, or injections) or an intrauterine device (e.g., Copper-T).
Who cannot join
- Participants meeting any of the exclusion criteria listed below at screening will be excluded from study participation.
- Current or anticipated use of other investigational agents.
- Patient has received chemotherapy or radiotherapy within 4 weeks prior to entering the study or has not recovered sufficiently (PI will judge patient recovery status) from adverse events due to agents administered more than 4 weeks earlier.
- Patient has history of or currently has non-peritoneal surface macroscopic metastatic disease in addition to peritoneal surface malignancy such as macroscopic pulmonary disease or other macroscopic disease outside of the peritoneal cavity.
- Patients with a current diagnosis of borderline epithelial ovarian tumor (formerly "tumors of low malignant potential") or recurrent invasive epithelial ovarian cancer treated with surgery only (such as those with stage Ia or Ib low Grade lesions) are not eligible. Patients with a prior diagnosis of a borderline tumor that was surgically resected and who subsequently develop an unrelated, new invasive epithelial ovarian or peritoneal primary cancer are eligible, provided that they have not received prior chemotherapy for any ovarian tumor.
- Patients with synchronous primary endometrial cancer, or a past history of primary endometrial cancer, are excluded, unless all of the following conditions are met: Stage not greater than I-B; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other International Federation of Gynecology and Obstetrics (FIGO) Grade 3 lesions.
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- ECOG 3 - 4
- Patients with history or current diagnosis of inflammatory bowel disease are not eligible.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Cisplatin, carboplatin and paclitaxel or other agents used in study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia
- Current psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant or nursing. There is a potential for congenital abnormalities and for this regimen to harm nursing infants.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The University of Kansas Cancer Center
Kansas City, Kansas, 66160-7357
Kerry Hepler, 913-945-7552, ctnursenav@kumc.edu
About this study
This study will evaluate the use of Heated Intraperitoneal Chemotherapy (HIPEC) for primary treatment of ovarian cancer at the time of surgical debulking, to assess if intravenous (IV) chemotherapy can be started within 42 days of HIPEC and cytoreduction. All patients will receive cytoreductive surgery followed by a one-time closed HIPEC with cisplatin at 41-43 degrees Celsius for 90 minutes in the operating room. This is followed by 6 cycles of intravenous carboplatin and paclitaxel on an outpatient basis.
Read the detailed description
Heated Intraperitoneal chemotherapy (HIPEC) has several potential benefits. High-dose chemotherapy can be used due to the plasma-peritoneal barrier resulting in little absorption into the blood stream. Additionally, there is higher peritoneal penetration in comparison to IV regimen, and does not have the limitation of traditional IP regimen of post-operative adhesions. Hyperthermia itself has cytotoxic effects and can increase the depth of tumor penetration by the chemotherapeutic agent up to 3 millimeters; moreover, hyperthermia can potentiate its antineoplastic effects.
In recent times, morbidity and mortality associated with HIPEC has drastically improved. One large retrospective review of 694 patients, treated between 2005 and 2011, utilizing the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQUIP) database, demonstrated a complication rate of 33% and 30-day mortality of 2.3%, both rates consistent with outcomes for other major complex abdominal operations.
Recently, a Phase I dose escalation study to evaluate maximum tolerated dose (MTD) of HIPEC administration of cisplatin in recurrent epithelial ovarian cancer (EOC) patients was published. The MTD of cisplatin was 100 milligrams per meter squared (mg/m2) with no mortality or safety concerns. While the trial had only 12 patients, all were able to receive post-operative IV chemotherapy, with all patients completing at least five cycles.
In protocol Gynecologic Oncology Group (GOG)-0172, intraperitoneal cisplatin and paclitaxel, plus intravenous paclitaxel, demonstrated the longest median survival reported in optimally debulked stage III ovarian cancer. Currently, the GOG is studying variations of the intraperitoneal (IP) regimen to preserve the survival advantage, but make it tolerable for patients to receive 6 cycles without discontinuing therapy due to distress and toxicity. The importance of developing an acceptable GOG-0172 alternative is emphasized by the recent National Cancer Institute (NCI) Clinical Announcement recognizing the superiority of intraperitoneal chemotherapy in the optimal disease setting.
- Being tested
- HIPEC, Carboplatin, Paclitaxel
- Keywords
- Heated intraperitoneal chemotherapy, HIPEC, cisplatin, paclitaxel, carboplatin, adjuvant IV chemotherapy
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIPECProcedure or surgery
HIPEC with cisplatin
CarboplatinDrug
Adjuvant IV chemotherapy
PaclitaxelDrug
Adjuvant IV chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| HIPEC + adjuvant IV chemotherapy | Experimental | HIPEC
* HIPEC will be administered intraoperatively one time only.
*HIPEC cisplatin will be administered at rate of 100 milligram per meter squared (mg/m2)
* Administration of HIPEC will have a duration of 90 minutes.
Adjuvant IV chemotherapy
* IV Paclitaxel
* Dose: 80mg/m2 IV over 1 hour
* Schedule: Days 1, 8 and 15
* Cycle Length: 3 weeks (21 days)
* IV Carboplatin
* Dose: Area under the curve (AUC) 6 IV
* Schedule: Day 1
* Cycle Length: 3 weeks (21 days) Receives: Procedure: HIPEC; Drug: Carboplatin; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to start of intravenous (IV) chemotherapy.
Time will be measured in days starting at the time of the completion of HIPEC surgery and ending at the time of initiation of chemotherapy.
Measured: 42 days
Secondary outcomes (7)
Chemotherapy-related adverse events.
Chemotherapy-related adverse events will be defined per the Common Terminology Criteria for Adverse Events (CTCAE) v4.03
Measured: 90 days
Proportion of deaths occurring in hospital.
Assess using Participant Electronic Medical Record indicating time of death.
Measured: Up to 2 years
Proportion of deaths occurring during post-hospital discharge period.
Assess using Participant Electronic Medical Record indicating time of death.
Measured: 30 days
Proportion of deaths occurring during post-hospital discharge.
Assess using Participant Electronic Medical Record indicating time of death.
Measured: 90 days
Average number of days in hospital Intensive Care Unit (ICU).
Assessed from the time of surgery until the transition out of ICU.
Measured: Up to 2 years
Average overall length of in-hospital stay.
Defined as days from the time of admission for surgery until discharge date of initial hospitalization
Measured: Up to 2 years
Average number of hospital re-admissions.
Assessed from the time of initial hospitalization discharge date.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start15 Dec 2017
- Primary completion15 Dec 2023 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrea Jewell
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kansas Medical Center
- Responsible party
- Sponsor-investigator, Andrea Jewell, University of Kansas Medical Center
- Investigators
- Andrea Jewell, MD, Principal investigator, The University of Kansas - Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321188
- Sponsor's protocol ID
- IIT-2017-HIPEC-Ovarian
- Status last verified
- Feb 2023
- First submitted
- 29 Jun 2017
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heated Intraperitoneal Chemotherapy in Primary Ovarian Cancer Patients
- ClinicalTrials.gov ID
- NCT03321188
- Acronym / sponsor ID
- IIT-2017-HIPEC-Ovarian
- Keywords
- Heated intraperitoneal chemotherapy, HIPEC, cisplatin, paclitaxel, carboplatin, adjuvant IV chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Andrea JewellUniversity, hospital or other
- Collaborators
- University of Kansas Medical Center
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 25 Oct 2017 (actual)
- 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 study will evaluate the use of Heated Intraperitoneal Chemotherapy (HIPEC) for primary treatment of ovarian cancer at the time of surgical debulking, to assess if intravenous (IV) chemotherapy can be started within 42 days of HIPEC and cytoreduction. All patients will receive cytoreductive surgery followed by a one-time closed HIPEC with cisplatin at 41-43 degrees Celsius for 90 minutes in the operating room. This is followed by 6 cycles of intravenous carboplatin and paclitaxel on an outpatient basis.
Detailed description
Heated Intraperitoneal chemotherapy (HIPEC) has several potential benefits. High-dose chemotherapy can be used due to the plasma-peritoneal barrier resulting in little absorption into the blood stream. Additionally, there is higher peritoneal penetration in comparison to IV regimen, and does not have the limitation of traditional IP regimen of post-operative adhesions. Hyperthermia itself has cytotoxic effects and can increase the depth of tumor penetration by the chemotherapeutic agent up to 3 millimeters; moreover, hyperthermia can potentiate its antineoplastic effects.
In recent times, morbidity and mortality associated with HIPEC has drastically improved. One large retrospective review of 694 patients, treated between 2005 and 2011, utilizing the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQUIP) database, demonstrated a complication rate of 33% and 30-day mortality of 2.3%, both rates consistent with outcomes for other major complex abdominal operations.
Recently, a Phase I dose escalation study to evaluate maximum tolerated dose (MTD) of HIPEC administration of cisplatin in recurrent epithelial ovarian cancer (EOC) patients was published. The MTD of cisplatin was 100 milligrams per meter squared (mg/m2) with no mortality or safety concerns. While the trial had only 12 patients, all were able to receive post-operative IV chemotherapy, with all patients completing at least five cycles.
In protocol Gynecologic Oncology Group (GOG)-0172, intraperitoneal cisplatin and paclitaxel, plus intravenous paclitaxel, demonstrated the longest median survival reported in optimally debulked stage III ovarian cancer. Currently, the GOG is studying variations of the intraperitoneal (IP) regimen to preserve the survival advantage, but make it tolerable for patients to receive 6 cycles without discontinuing therapy due to distress and toxicity. The importance of developing an acceptable GOG-0172 alternative is emphasized by the recent National Cancer Institute (NCI) Clinical Announcement recognizing the superiority of intraperitoneal chemotherapy in the optimal disease setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIPEC + adjuvant IV chemotherapy | Experimental | Procedure: HIPEC, Drug: Carboplatin, Drug: PaclitaxelHIPEC * HIPEC will be administered intraoperatively one time only. *HIPEC cisplatin will be administered at rate of 100 milligram per meter squared (mg/m2) * Administration of HIPEC will have a duration of 90 minutes. Adjuvant IV chemotherapy * IV Paclitaxel * Dose: 80mg/m2 IV over 1 hour * Schedule: Days 1, 8 and 15 * Cycle Length: 3 weeks (21 days) * IV Carboplatin * Dose: Area under the curve (AUC) 6 IV * Schedule: Day 1 * Cycle Length: 3 weeks (21 days) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Ability to understand and the willingness to sign a written informed consent.
- Patients with a histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, Stage 3(III)B - 3(III)C with optimal (≤ 1 centimeter) residual disease.
- Patients with the following histologic epithelial cell types are eligible:
- Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified.
- No previous HIPEC.
Key exclusion criteria (12 listed)
- Participants meeting any of the exclusion criteria listed below at screening will be excluded from study participation.
- Current or anticipated use of other investigational agents.
- Patient has received chemotherapy or radiotherapy within 4 weeks prior to entering the study or has not recovered sufficiently (PI will judge patient recovery status) from adverse events due to agents administered more than 4 weeks earlier.
- Patient has history of or currently has non-peritoneal surface macroscopic metastatic disease in addition to peritoneal surface malignancy such as macroscopic pulmonary disease or other macroscopic disease outside of the peritoneal cavity.
- Patients with a current diagnosis of borderline epithelial ovarian tumor (formerly "tumors of low malignant potential") or recurrent invasive epithelial ovarian cancer treated with surgery only (such as those with stage Ia or Ib low Grade lesions) are not eligible. Patients with a prior diagnosis of a borderline tumor that was surgically resected and who subsequently develop an unrelated, new invasive epithelial ovarian or peritoneal primary cancer are eligible, provided that they have not received prior chemotherapy for any ovarian tumor.
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 |
|---|---|---|
| HIPECHIPEC with cisplatin | Procedure or surgery | HIPEC + adjuvant IV chemotherapy |
| CarboplatinAdjuvant IV chemotherapy | Drug | HIPEC + adjuvant IV chemotherapy |
| PaclitaxelAdjuvant IV chemotherapy | Drug | HIPEC + adjuvant IV chemotherapy |
Primary outcome
Time to start of intravenous (IV) chemotherapy.
Time frame: 42 days
Time will be measured in days starting at the time of the completion of HIPEC surgery and ending at the time of initiation of chemotherapy.
7 secondary outcomes
Chemotherapy-related adverse events.
Time frame: 90 days
Proportion of deaths occurring in hospital.
Time frame: Up to 2 years
Proportion of deaths occurring during post-hospital discharge period.
Time frame: 30 days
Proportion of deaths occurring during post-hospital discharge.
Time frame: 90 days
Average number of days in hospital Intensive Care Unit (ICU).
Time frame: Up to 2 years
Average overall length of in-hospital stay.
Time frame: Up to 2 years
Average number of hospital re-admissions.
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Andrea Jewell, MD principal investigator
The University of Kansas - 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 2 study testing HIPEC, Carboplatin and Paclitaxel in people with Ovarian Cancer and Epithelial Ovarian Cancer, run by Andrea Jewell 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 21 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 6 Feb 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nurse Navigator (913-945-7552, ctnursenav@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to start of intravenous (IV) chemotherapy. (time frame: 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2023.