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HIPEC After Surgery for Ovarian Cancer

Phase 1

Recruiting

Led By Jill Whyte, MD

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed cancer of the ovary, fallopian tube or peritoneum

Disease limited to the abdomen and pelvis that is amenable to complete CRS indicated by:

Must not have

Prior chemotherapy (other than NACT) or whole abdomen radiation for ovarian, fallopian tube or primary peritoneal cancers

Patients with an active second malignancy regardless of site

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is for women with ovarian, fallopian tube, or primary peritoneal cancer who have undergone 3 cycles of neoadjuvant chemotherapy and are eligible for cytoreductive surgery. The trial will evaluate the feasibility, toxicity, and tolerability of heated intraoperative peritoneal chemotherapy administered after neoadjuvant chemotherapy.

Who is the study for?

This trial is for women over 18 with ovarian, fallopian tube, or peritoneal cancer who've had a positive response to initial chemotherapy. They must be in good heart and lung health, not pregnant or breastfeeding, without other cancers or severe illnesses that could interfere with the study.

What is being tested?

The trial tests heated intraoperative peritoneal chemotherapy (HIPEC) after three cycles of neoadjuvant chemotherapy (NACT) and surgery in patients whose tumors can potentially be completely removed. The focus is on feasibility and safety of HIPEC post-NACT.

What are the potential side effects?

Potential side effects include those related to cisplatin such as kidney damage, hearing loss, nerve issues like numbness or tingling, nausea and vomiting. Surgery-related risks may also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer originates from the ovary, fallopian tube, or peritoneum.

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My disease is only in my abdomen and pelvis and can be fully removed by surgery.

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My cancer is only in the lining of my abdomen.

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My cancer has not spread to distant parts of my body.

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My liver tests are within the normal range.

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My kidney function, measured by creatinine levels, is normal or nearly normal.

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My heart and lung health is good enough for major surgery.

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I am older than 18 years.

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I can perform all self-care but cannot work.

Exclusion Criteria

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

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I have had chemotherapy or radiation for ovarian, fallopian tube, or peritoneal cancer.

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I have another active cancer besides the one being studied.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I was diagnosed with a non-gynecologic cancer during surgery.

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My cancer is a low-grade or borderline gynecologic type.

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I have heart or lung conditions that prevent major surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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

Morbidity, assessed by the occurrence of adverse events and serious adverse events

Mortality

Safety data obtained from scheduled exams

Secondary study objectives

Ability to complete systemic IV chemotherapy after IDS and HIPEC

Achievement of hyperthermia

Completeness of surgical cytoreduction

+2 more

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680

51%

Neutropenia

47%

Leukopenia

46%

Nausea

43%

Vomiting

35%

Anaemia

31%

Decreased appetite

26%

Haemoglobin decreased

26%

Fatigue

25%

Constipation

25%

White blood cell count decreased

24%

Neutrophil count decreased

19%

Alanine aminotransferase increased

13%

Platelet count decreased

12%

Rash

10%

Aspartate aminotransferase increased

10%

Thrombocytopenia

Blood sodium decreased

Hypokalaemia

Insomnia

Pyrexia

Hyponatraemia

Blood creatinine increased

Lymphopenia

Diarrhoea

Dyspepsia

Red blood cell count decreased

Cough

Dizziness

Bone marrow failure

Ischaemic stroke

Dyspnoea

Cerebral infarction

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Gemcitabine Plus Cisplatin (GC)

Pemetrexed Plus Cisplatin (PC)

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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 Treatment1 Intervention

Patient will receive HIPEC in the form of Cisplatin 100mg/m2. 5. HIPEC will be provided at completion of surgical cytoreduction. The chemotherapy will be ordered by the treating gynecologic oncologist. It will be prepared in the chemotherapy pharmacy and delivered to the operating room once the surgeon confirms optimal cytoreduction and eligibility. Patients undergoing bowel resection will be left with bowel in discontinuity during the HIPEC infusion cycle. The abdomen will be temporarily closed with skin staples to prevent spillage of the perfusate. HIPEC will be delivered using the closed technique as has been well described.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

FDA approved

0 / 15Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor

475 Previous Clinical Trials

469,269 Total Patients Enrolled

Katie Oppo Research FundUNKNOWN

Jill Whyte, MD4.413 ReviewsPrincipal Investigator - Northwell Health

Northwell Health

5Patient Review

Dr. Whyte was highly recommended to me by my gynecologist, and she did not disappoint. She was the consummate professional, and made me feel like I was her only patient. I would recommend her to anyone.