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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
Age ≥ 18 years
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
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 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
472 Previous Clinical Trials
171,419 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
~3 spots leftby Jun 2025