Heated Intraperitoneal Chemotherapy in Primary Ovarian Cancer Patients
1 other identifier
interventional
20
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 ovarian-cancer
Started Dec 2017
Longer than P75 for phase_2 ovarian-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2017
CompletedFirst Posted
Study publicly available on registry
October 25, 2017
CompletedStudy Start
First participant enrolled
December 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2024
CompletedFebruary 6, 2023
February 1, 2023
6 years
June 29, 2017
February 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
42 days
Secondary Outcomes (7)
Chemotherapy-related adverse events.
90 days
Proportion of deaths occurring in hospital.
Up to 2 years
Proportion of deaths occurring during post-hospital discharge period.
30 days
Proportion of deaths occurring during post-hospital discharge.
90 days
Average number of days in hospital Intensive Care Unit (ICU).
Up to 2 years
- +2 more secondary outcomes
Study Arms (1)
HIPEC + adjuvant IV chemotherapy
EXPERIMENTALHIPEC * 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)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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
- +6 more criteria
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Andrea Jewelllead
- University of Kansas Medical Centercollaborator
Study Sites (1)
The University of Kansas Cancer Center
Kansas City, Kansas, 66160-7357, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Jewell, MD
The University of Kansas - Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
June 29, 2017
First Posted
October 25, 2017
Study Start
December 15, 2017
Primary Completion
December 15, 2023
Study Completion
December 15, 2024
Last Updated
February 6, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share