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HIPEC After Initial CRS in Patients Who Have Received NACT

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ClinicalTrials.gov Identifier: NCT03540017
Recruitment Status : Recruiting
First Posted : May 30, 2018
Last Update Posted : July 30, 2019
Sponsor:
Collaborator:
Katie Oppo Foundation
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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
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 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.



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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03540017


Contacts
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Contact: Jill S Whyte, MD 5165624438 jwhyte@northwell.edu
Contact: Aaron Nizam, MD anizam1@northwell.edu

Locations
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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    jwhyte@northwell.edu   
Sponsors and Collaborators
Northwell Health
Katie Oppo Foundation
Investigators
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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
ClinicalTrials.gov Identifier: NCT03540017     History of Changes
Other Study ID Numbers: IRB #: 18-0153
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
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
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Cisplatin
Antineoplastic Agents