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Alkylating agents

HIPEC for Recurrent Ovarian Cancer

Phase 1
Recruiting
Led By Mazdak Momeni, MD
Research Sponsored by Loma Linda University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with diagnosis of epithelial ovarian carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma that has recurred >6 months since platinum-based chemotherapy (first recurrence) and are scheduled for secondary surgical evaluation/cytoreduction
No End organ function
Must not have
Patients with active coronary artery disease
Patients with known acute hepatitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months after the day of surgery
Awards & highlights
No Placebo-Only Group

Summary

This trial is comparing the effectiveness of two different treatments for ovarian, primary peritoneal, or fallopian tube cancer that has come back. One treatment is surgery to remove as much of the cancer as possible, followed by a single dose of chemotherapy given through the abdomen directly to the area where the cancer was. The other treatment is 6 cycles of standard chemotherapy given intravenously.

Who is the study for?
This trial is for adults over 21 with recurrent ovarian, primary peritoneal, or fallopian tube cancers after initial platinum-based chemotherapy. They must have minimal residual disease post-surgery and be in good physical condition. Excluded are those with prior abdominal radiation, other recent cancers, low malignant potential tumors, heart disease, acute hepatitis, severe lung issues, compromised immune systems, known allergies to carboplatin or cisplatin, metastatic disease outside the abdomen or a life expectancy under 3 months.
What is being tested?
The study tests the effectiveness of combining surgical cytoreduction (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) using Carboplatin in patients with recurrent ovarian cancer. After surgery leaving ≤2.5 mm residual disease and HIPEC treatment at high temperatures for 90 minutes follows standard IV platinum-based chemotherapy cycles.
What are the potential side effects?
Potential side effects include reactions to Carboplatin such as nausea and vomiting; complications from surgery; risks associated with hyperthermia like burns or heatstroke; and general chemo-related side effects like fatigue, blood disorders and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My ovarian, peritoneal, or fallopian tube cancer has returned more than 6 months after platinum chemotherapy.
Select...
My organs are functioning properly.
Select...
My surgery left 2.5 mm or less of the disease.
Select...
I am over 21 years old.
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I can carry out all my usual activities without help.
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My cancer is one of the specified types like serous or clear cell.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have active heart artery disease.
Select...
I have been diagnosed with acute hepatitis.
Select...
I have a lung condition that makes it hard to breathe.
Select...
My cancer has spread beyond my abdomen.
Select...
I have not had radiation therapy to my abdomen or pelvis.
Select...
I haven't had any other cancers in the last 3 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months after the day of surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months after the day of surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Recurrence-free survival compared to historical controls

Side effects data

From 2022 Phase 3 trial • 1301 Patients • NCT03038100
60%
ALOPECIA
51%
NAUSEA
45%
ARTHRALGIA
44%
ANAEMIA
38%
FATIGUE
35%
CONSTIPATION
35%
DIARRHOEA
35%
HYPERTENSION
30%
NEUTROPENIA
28%
ABDOMINAL PAIN
28%
NEUTROPHIL COUNT DECREASED
28%
PERIPHERAL SENSORY NEUROPATHY
24%
NEUROPATHY PERIPHERAL
24%
RASH
23%
VOMITING
23%
HEADACHE
22%
WHITE BLOOD CELL COUNT DECREASED
22%
MYALGIA
21%
PLATELET COUNT DECREASED
21%
PROTEINURIA
21%
EPISTAXIS
21%
THROMBOCYTOPENIA
19%
DECREASED APPETITE
18%
HYPOTHYROIDISM
17%
URINARY TRACT INFECTION
16%
PYREXIA
16%
COUGH
15%
STOMATITIS
14%
ALANINE AMINOTRANSFERASE INCREASED
14%
ASPARTATE AMINOTRANSFERASE INCREASED
14%
HYPOMAGNESAEMIA
14%
BACK PAIN
14%
INSOMNIA
14%
DYSPNOEA
14%
PRURITUS
13%
WEIGHT DECREASED
13%
PAIN IN EXTREMITY
12%
ASTHENIA
12%
INFUSION RELATED REACTION
12%
DIZZINESS
11%
LEUKOPENIA
11%
HYPOKALAEMIA
10%
UPPER RESPIRATORY TRACT INFECTION
9%
DYSGEUSIA
8%
FEBRILE NEUTROPENIA
8%
ABDOMINAL PAIN UPPER
8%
HYPOAESTHESIA
8%
WEIGHT INCREASED
8%
HYPERTHYROIDISM
7%
MUCOSAL INFLAMMATION
7%
LYMPHOCYTE COUNT DECREASED
7%
HYPONATRAEMIA
7%
BONE PAIN
7%
MUSCULAR WEAKNESS
7%
PARAESTHESIA
7%
DYSPHONIA
7%
OROPHARYNGEAL PAIN
7%
DYSPEPSIA
7%
RASH MACULO-PAPULAR
7%
HYPERGLYCAEMIA
6%
OEDEMA PERIPHERAL
6%
BLOOD ALKALINE PHOSPHATASE INCREASED
6%
NASOPHARYNGITIS
6%
ABDOMINAL DISTENSION
6%
ANXIETY
5%
DRY MOUTH
5%
MALAISE
5%
DEPRESSION
5%
NASAL CONGESTION
5%
PAIN
5%
VISION BLURRED
5%
DRY SKIN
5%
URTICARIA
5%
HOT FLUSH
5%
NECK PAIN
4%
GASTROOESOPHAGEAL REFLUX DISEASE
2%
ILEUS
2%
PNEUMONIA
2%
PULMONARY EMBOLISM
2%
COLITIS
2%
SMALL INTESTINAL OBSTRUCTION
1%
INTESTINAL OBSTRUCTION
1%
LIVER INJURY
1%
PERITONITIS
1%
UROSEPSIS
1%
DEHYDRATION
1%
TRANSIENT ISCHAEMIC ATTACK
1%
PNEUMONITIS
1%
ABDOMINAL ABSCESS
1%
INFECTED LYMPHOCELE
1%
PYELONEPHRITIS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo With Paclitaxel, Carboplatin and Bevacizumab
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab

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: HIPECExperimental Treatment2 Interventions
A procedure in which the internal parts of your abdomen are bathed in a warm solution of anti-cancer medications for 90 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6120
Hyperthermic intraperitoneal chemotherapy (HIPEC)
2016
Completed Phase 2
~200

Find a Location

Who is running the clinical trial?

Loma Linda UniversityLead Sponsor
316 Previous Clinical Trials
266,680 Total Patients Enrolled
Mazdak Momeni, MDPrincipal Investigator - Loma Linda University Cancer Center
Loma Linda University Children's Hospital, Loma Linda University Medical Center

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02672098 — Phase 1
Ovarian Cancer Research Study Groups: HIPEC
Ovarian Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT02672098 — Phase 1
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02672098 — Phase 1
~1 spots leftby Apr 2025
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