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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months after the day of surgery
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My ovarian, peritoneal, or fallopian tube cancer has returned more than 6 months after platinum chemotherapy.
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My organs are functioning properly.
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My surgery left 2.5 mm or less of the disease.
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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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months after the day of surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months after the day of surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recurrence-free survival compared to historical controls
Side effects data
From 2022 Phase 3 trial • 1301 Patients • NCT0303810060%
ALOPECIA
51%
NAUSEA
45%
ARTHRALGIA
44%
ANAEMIA
38%
FATIGUE
35%
HYPERTENSION
35%
CONSTIPATION
35%
DIARRHOEA
30%
NEUTROPENIA
28%
PERIPHERAL SENSORY NEUROPATHY
28%
ABDOMINAL PAIN
28%
NEUTROPHIL COUNT DECREASED
24%
NEUROPATHY PERIPHERAL
24%
RASH
23%
HEADACHE
23%
VOMITING
22%
WHITE BLOOD CELL COUNT DECREASED
22%
MYALGIA
21%
PROTEINURIA
21%
EPISTAXIS
21%
PLATELET COUNT DECREASED
21%
THROMBOCYTOPENIA
19%
DECREASED APPETITE
18%
HYPOTHYROIDISM
17%
URINARY TRACT INFECTION
16%
COUGH
16%
PYREXIA
15%
STOMATITIS
14%
HYPOMAGNESAEMIA
14%
ASPARTATE AMINOTRANSFERASE INCREASED
14%
BACK PAIN
14%
INSOMNIA
14%
ALANINE AMINOTRANSFERASE INCREASED
14%
DYSPNOEA
14%
PRURITUS
13%
WEIGHT DECREASED
13%
PAIN IN EXTREMITY
12%
DIZZINESS
12%
INFUSION RELATED REACTION
12%
ASTHENIA
11%
LEUKOPENIA
11%
HYPOKALAEMIA
10%
UPPER RESPIRATORY TRACT INFECTION
9%
DYSGEUSIA
8%
ABDOMINAL PAIN UPPER
8%
FEBRILE NEUTROPENIA
8%
HYPOAESTHESIA
8%
WEIGHT INCREASED
8%
HYPERTHYROIDISM
7%
BONE PAIN
7%
LYMPHOCYTE COUNT DECREASED
7%
DYSPHONIA
7%
MUCOSAL INFLAMMATION
7%
MUSCULAR WEAKNESS
7%
HYPONATRAEMIA
7%
PARAESTHESIA
7%
OROPHARYNGEAL PAIN
7%
DYSPEPSIA
7%
RASH MACULO-PAPULAR
7%
HYPERGLYCAEMIA
6%
BLOOD ALKALINE PHOSPHATASE INCREASED
6%
OEDEMA PERIPHERAL
6%
NASOPHARYNGITIS
6%
ABDOMINAL DISTENSION
6%
ANXIETY
5%
PAIN
5%
DEPRESSION
5%
DRY MOUTH
5%
MALAISE
5%
NASAL CONGESTION
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%
PERITONITIS
1%
LIVER INJURY
1%
INTESTINAL OBSTRUCTION
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
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
Hyperthermic intraperitoneal chemotherapy (HIPEC)
2016
Completed Phase 2
~200
Carboplatin
2014
Completed Phase 3
~6670
Find a Location
Who is running the clinical trial?
Loma Linda UniversityLead Sponsor
306 Previous Clinical Trials
260,968 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My tumor is considered to be low-grade.I have active heart artery disease.I have been diagnosed with acute hepatitis.My ovarian, peritoneal, or fallopian tube cancer has returned more than 6 months after platinum chemotherapy.I have a lung condition that makes it hard to breathe.My cancer has spread beyond my abdomen.Patients with weakened immune systems.You are allergic to carboplatin or cisplatin.My organs are functioning properly.My surgery left 2.5 mm or less of the disease.I have not had radiation therapy to my abdomen or pelvis.I am over 21 years old.I can carry out all my usual activities without help.My cancer is one of the specified types like serous or clear cell.I haven't had any other cancers in the last 3 years.You are expected to live for less than 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: HIPEC
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the government given Carboplatin clearance for medical use?
"Based on our research, the safety of carboplatin has been determined to be a 1 due to limited clinical data and its status as a Phase 1 trial."
Answered by AI
How many individuals are currently being monitored in this research endeavor?
"Indeed, clinicaltrials.gov data reveals that this examination is now seeking applicants; the trial was originally posted on July 14th 2016 and recently updated on May 2nd 2022. The team behind this venture requires 20 participants from a single site to ensure successful results."
Answered by AI
Is it possible to join this trial as a participant?
"Affirmative. Information on clinicaltrials.gov indicates that this experiment is at present endeavouring to recruit volunteers, which was first published in July 14th 2016 and most recently updated on May 2nd 2022. They are seeking 20 participants from 1 site."
Answered by AI
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