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Procedure

HIPEC + IV Chemotherapy for Ovarian Cancer

Phase 2
Recruiting
Led By Andrea Jewell, MD
Research Sponsored by Andrea Jewell
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial will test if treating ovarian cancer with Heated Intraperitoneal Chemotherapy (HIPEC) followed by intravenous (IV) chemotherapy can start within 42 days of HIPEC.

Who is the study for?
This trial is for women over 18 with certain types of ovarian, fallopian tube, or primary peritoneal carcinoma at stage IIIB-III C after optimal surgery. They must have good organ function and no history of HIPEC treatment or severe allergies to the drugs used in this study. Participants should not be pregnant, nursing, or have serious illnesses that could affect their participation.Check my eligibility
What is being tested?
The study tests Heated Intraperitoneal Chemotherapy (HIPEC) during debulking surgery for ovarian cancer followed by IV chemotherapy with carboplatin and paclitaxel. The goal is to see if IV chemotherapy can start within 42 days post-HIPEC and how effective this combination is against the cancer.See study design
What are the potential side effects?
Possible side effects include reactions to cisplatin like kidney damage, hearing loss, nerve problems; carboplatin may cause low blood counts leading to infection risk; paclitaxel can cause allergic reactions, joint/muscle pain and impact blood cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for surgery to remove as much of the cancer as possible.
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I am 18 years old or older.
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My blood counts and liver/kidney functions are within normal ranges.
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I have ovarian, fallopian tube, or peritoneal cancer at Stage 3B-3C with minimal remaining disease.
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My cancer is one of the specified types of epithelial cell cancer.
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I have never had HIPEC treatment.
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I can take care of myself and am up and about more than half of the day.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to start of intravenous (IV) chemotherapy.
Secondary outcome measures
Average number of days in hospital Intensive Care Unit (ICU).
Average number of hospital re-admissions.
Average overall length of in-hospital stay.
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: HIPEC + adjuvant IV chemotherapyExperimental Treatment3 Interventions
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)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
HIPEC
2014
Completed Phase 3
~230
Carboplatin
2014
Completed Phase 3
~6670

Find a Location

Who is running the clinical trial?

Andrea JewellLead Sponsor
University of Kansas Medical CenterOTHER
459 Previous Clinical Trials
169,084 Total Patients Enrolled
2 Trials studying Ovarian Cancer
52 Patients Enrolled for Ovarian Cancer
Andrea Jewell, MDPrincipal InvestigatorThe University of Kansas - Cancer Center

Media Library

HIPEC (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03321188 — Phase 2
Ovarian Cancer Research Study Groups: HIPEC + adjuvant IV chemotherapy
Ovarian Cancer Clinical Trial 2023: HIPEC Highlights & Side Effects. Trial Name: NCT03321188 — Phase 2
HIPEC (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03321188 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment period for this research study currently accessible to participants?

"As of today, this medical study is still recruiting participants. It was initially published on December 15th 2017 and the latest update to its page occurred on January 21st 2022."

Answered by AI

How many individuals are being enrolled in this clinical experiment?

"Correct, according to records on clinicaltrials.gov this study is actively recruiting participants. It was first posted in December 2017 and most recently updated in January 2022 with the aim of enrolling 20 people at one site."

Answered by AI

Has the use of HIPEC been examined in other research efforts?

"Presently, 1174 investigations into HIPEC are underway with 332 in their final phase. Of these trials, the majority originate from Shanghai; however, there exist 66513 different sites where such studies may be conducted."

Answered by AI

Has the FDA given clearance to use HIPEC?

"HIPEC's safety has been largely corroborated in Phase 2 clinical trials, so it was rated a 2."

Answered by AI

In what scenarios do medical professionals commonly deploy HIPEC treatments?

"HIPEC is a viable solution for managing the growth of melanoma, neoplasm metastasis, and non-Hodgkin's lymphoma."

Answered by AI
~3 spots leftby Mar 2025