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HIPEC After Initial CRS in Patients Who Have Received NACT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03540017
Recruitment Status : Recruiting
First Posted : May 30, 2018
Last Update Posted : March 11, 2020
Katie Oppo Research Fund
Information provided by (Responsible Party):
Jill Whyte, Northwell Health

Brief Summary:

The majority of women diagnosed with ovarian, fallopian tube and primary peritoneal cancer present with advanced stage III and IV disease. Despite aggressive surgery and systemic chemotherapy, the majority of patients will relapse. Five year survival remains only 20-35% for patients diagnosed with bulky stage IIIC and IV cancers. Patients who are not candidates for an initial cytoreductive surgery at the time of diagnosis form a particularly poor prognosis group. These patients are treated with neoadjuvant chemotherapy (NACT) and will ultimately undergo cytoreductive surgery provided there is a response to chemotherapy. New therapies for this cohort of women are urgently needed.

The investigators have designed a pilot study to evaluate the feasibility of heated intraoperative peritoneal chemotherapy (HIPEC) given at the time of interval cytoreductive surgery after 3 cycles of NACT. Patients undergoing NACT for ovarian, fallopian tube or primary peritoneal cancer will be evaluated after their third cycle of chemotherapy for trial participation. Patient meeting eligibility criteria will proceed with cytoreductive surgery. HIPEC will be administered in those patients in whom optimal tumor cytoreduction is achieved. Primary objective of this study is to evaluate the feasibility, toxicity and tolerability of HIPEC administered after NACT.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Carcinoma Drug: Cisplatin Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Heated Intraperitoneal Chemotherapy (HIPEC) After Interval Cytoreductive Surgery (CRS) in Patients Who Have Received Neoadjuvant Chemotherapy (NACT) for Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancers
Actual Study Start Date : March 12, 2019
Estimated Primary Completion Date : July 5, 2020
Estimated Study Completion Date : July 1, 2024

Arm Intervention/treatment
Experimental: HIPEC
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.
Drug: Cisplatin
Heated Intraperitoneal Chemotherapy will be administered after the completion of interval cytoreductive surgery after three cycles of neoadjuvant chemotherapy.

Primary Outcome Measures :
  1. Morbidity, assessed by the occurrence of adverse events and serious adverse events [ Time Frame: 30 days ]
    Severity of adverse events will be evaluated using the NCI Common Terminology Criteria for Adverse Events version 4.0 [NCI CTCAE v4.0]. AEs will be classified as possibly, probably, or definitely related to study treatment.

  2. Safety data obtained from scheduled exams [ Time Frame: 1 year ]
    Physical examinations, vital signs, hematologic and clinical parameters, measured monthly for 12 months after initial study treatment or subject discontinuation, whichever comes first.

  3. Mortality [ Time Frame: 5 years ]
    Time from surgery date to death due to any cause.

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 5 years ]
    Time from surgery date to the first documentation of disease progression or death due to any cause.

  2. Ability to complete systemic IV chemotherapy after IDS and HIPEC [ Time Frame: 1 year ]
    Patient completion of systemic IV chemotherapy after surgery and HIPEC.

  3. Functional Assessment of Cancer Therapy-Ovarian (FACT-O) [ Time Frame: 2 years ]
    Survey administered to assess for quality of life.

  4. Completeness of surgical cytoreduction [ Time Frame: 24 hours ]
    Complete cytoreduction will be determined as having a CC score of 0 or 1

  5. Achievement of hyperthermia [ Time Frame: 24 hours ]
    Target intra-peritoneal temperature of 41-43°C.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically confirmed cancer of the ovary, fallopian tube or peritoneum.
  2. Women of all races and ethnicities are eligible for this trial.
  3. Age > 18.
  4. The patient must have documented disease limited to the abdomen and pelvis that is amenable to complete CRS indicated by:

    1. Disease confined to the peritoneal surfaces.
    2. No clinical or radiological evidence of hematogenous or distant (extra-abdominal) nodal metastasis.
  5. Evidence of response to NACT must as documented by at least one of the following: decline in serum CA125 level, at least a 30% decrease in the sum of the longest diameter of target lesions on radiographic imaging, or resolution of ascites or pleural effusion(s).
  6. Gynecologic Oncology Group (GOG) performance status <= 2
  7. Leukocytes >= 3,000/microliter (mcL), absolute neutrophil count >= 1,500/mcL, platelets >= 100,000/mcL
  8. Adequate hepatic function as measured by total bilirubin within normal institutional limits, aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase (SGOT))/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase (SGPT)) =< 2.5 x institutional upper limit of normal
  9. Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min for patients with creatinine levels above institutional normal
  10. Albumin >= 2.5 mg/dL
  11. Satisfactory cardiopulmonary function (no history of severe congestive heart failure or severe pulmonary disease, as indicated by clinically acceptable risks to undergo major abdominal surgery
  12. Voluntary participation after getting written informed consent

Exclusion Criteria:

  1. Prior chemotherapy (other than NACT) or whole abdomen radiation for ovarian, fallopian tube or primary peritoneal cancers.
  2. Patients with an active second malignancy regardless of site.
  3. Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  4. Pregnant or breast-feeding patients
  5. Patients who are receiving other oncologic investigational therapeutic agents
  6. Patients receiving NACT whose disease has progressed following at least 3 cycles of platinum-based therapy, defined by at least one of the following: clinical deterioration (new or worsening of existing ascites, carcinomatous ileus, malignant bowel obstruction, declining performance status); new lesion(s) or increase in maximal diameter of > 20% of the two largest target lesions; rising CA-125 (an increase of at least 10% of baseline value that increases over 3 values obtained every 21 days).
  7. Cardiac or pulmonary conditions that preclude aggressive cytoreductive surgery.
  8. Patients found to have non-gynecologic cancer at the time of surgery.
  9. Patients with gynecologic malignancy of low-grade serous or borderline histology.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03540017

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Contact: Jill S Whyte, MD 5165624438
Contact: Aaron Nizam, MD

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United States, New York
Long Island Jewish Medical Center Recruiting
New Hyde Park, New York, United States, 11040
Contact: Jill Whyte, MD    516-562-4438   
Sponsors and Collaborators
Northwell Health
Katie Oppo Research Fund
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Principal Investigator: Jill Whyte, MD Northwell Health
Publications of Results:

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Responsible Party: Jill Whyte, Physician, Northwell Health Identifier: NCT03540017    
Other Study ID Numbers: IRB #: 18-0153
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jill Whyte, Northwell Health:
Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Antineoplastic Agents