Heated Intraperitoneal Chemotherapy in Primary Ovarian Cancer Patients
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|ClinicalTrials.gov Identifier: NCT03321188|
Recruitment Status : Recruiting
First Posted : October 25, 2017
Last Update Posted : July 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer Epithelial Ovarian Cancer Fallopian Tube Cancer||Procedure: HIPEC Drug: Carboplatin Drug: Paclitaxel||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Heated Intraperitoneal Chemotherapy in Primary Ovarian Cancer Patients|
|Actual Study Start Date :||December 15, 2017|
|Estimated Primary Completion Date :||December 15, 2020|
|Estimated Study Completion Date :||December 15, 2020|
Experimental: HIPEC + adjuvant IV chemotherapy
Adjuvant IV chemotherapy
HIPEC with cisplatin
Adjuvant IV chemotherapy
Adjuvant IV chemotherapy
- 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.
- Chemotherapy-related adverse events. [ Time Frame: 90 days ]Chemotherapy-related adverse events will be defined per the Common Terminology Criteria for Adverse Events (CTCAE) v4.03
- Proportion of deaths occurring in hospital. [ Time Frame: Up to 2 years ]Assess using Participant Electronic Medical Record indicating time of death.
- Proportion of deaths occurring during post-hospital discharge period. [ Time Frame: 30 days ]Assess using Participant Electronic Medical Record indicating time of death.
- Proportion of deaths occurring during post-hospital discharge. [ Time Frame: 90 days ]Assess using Participant Electronic Medical Record indicating time of death.
- Average number of days in hospital Intensive Care Unit (ICU). [ Time Frame: Up to 2 years ]Assessed from the time of surgery until the transition out of ICU.
- Average overall length of in-hospital stay. [ Time Frame: Up to 2 years ]Defined as days from the time of admission for surgery until discharge date of initial hospitalization
- Average number of hospital re-admissions. [ Time Frame: 90 days ]Assessed from the time of initial hospitalization discharge date.
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): NCT03321188
|Contact: Nurse Navigatorfirstname.lastname@example.org|
|United States, Kansas|
|The University of Kansas Cancer Center||Recruiting|
|Kansas City, Kansas, United States, 66160-7357|
|Contact: Kerry Hepler 913-945-7552 email@example.com|
|Principal Investigator:||Andrea Jewell, MD||The University of Kansas - Cancer Center|