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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

Must not have

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 history or current diagnosis of inflammatory bowel disease are not eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have cancer that has spread beyond my abdomen.

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I do not have and have never had inflammatory bowel disease.

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I do not have any serious ongoing illnesses like heart problems or infections.

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I do not have a borderline ovarian tumor or recurrent ovarian cancer treated with surgery only.

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I am not pregnant or nursing.

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I need considerable assistance and can't do any physical work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to start of intravenous (IV) chemotherapy.

Secondary study objectives

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

Side effects data

From 2024 Phase 2 trial • 51 Patients • NCT02040142

69%

Anemia

59%

Hypocalcemia

55%

Nausea

53%

Hypertension

49%

Lymphocyte Count Decreased

49%

Hyperglycemia

47%

Aspartate Aminotransferase (AST) Increased

45%

Blood Bilirubin Increased

43%

Alanine Aminotransferase (ALT) Increased

37%

White Blood Cell Decreased

29%

Hypoalbuminemia

22%

Febrile Neutropenia

Fever

Creatinine Increased

Chronic Kidney Disease

Hypophosphatemia

Acute Kidney Injury

Dyspnea

White Blood Cell Count Increased

Platelet Count Decreased

Intra-abdominal Hemorrhage

Abdominal Pain

100%

80%

60%

40%

20%

Study treatment Arm

HIPEC + Mitomycin C

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~5450

HIPEC

2014

Completed Phase 3

~230