RECRUITING

HIPEC After Initial CRS in Patients Who Have Received NACT

Conditions

Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Carcinoma Primary Peritoneal Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2019-03-12

Study Completion:2025-07-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03540017

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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.

Inclusion Criteria

Exclusion 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

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.

Contacts and Locations

Study Contact

Jill S Whyte, MD

CONTACT

5165624438

jwhyte@northwell.edu

Aaron Nizam, MD

CONTACT

anizam1@northwell.edu

Principal Investigator

Jill Whyte, MD

PRINCIPAL_INVESTIGATOR

Northwell Health

Study Locations (Sites)

Long Island Jewish Medical Center

New Hyde Park, New York, 11040

United States

Collaborators and Investigators

Sponsor: Northwell Health

Jill Whyte, MD, PRINCIPAL_INVESTIGATOR, Northwell Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-03-12

Study Completion Date2025-07-05

Study Record Updates

Study Start Date2019-03-12

Study Completion Date2025-07-05

Terms related to this study

Keywords Provided by Researchers

Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer

Additional Relevant MeSH Terms

Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Carcinoma