Heated chemotherapy after surgery for advanced ovarian cancer
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
This study is testing whether giving heated chemotherapy during surgery can help women with advanced ovarian cancer who have already responded to other treatments feel better and improve their outcomes.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | Female |
| Sponsor | Northwell Health Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (New Hyde Park, New York) |
| Trial ID | NCT03540017 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the feasibility of administering heated intraoperative peritoneal chemotherapy (HIPEC) during interval cytoreductive surgery for women with advanced ovarian, fallopian tube, or primary peritoneal cancer who have responded to neoadjuvant chemotherapy (NACT). The study aims to improve outcomes for patients who are not candidates for initial surgery due to advanced disease. Participants will undergo HIPEC with cisplatin after three cycles of NACT, with the goal of enhancing the effectiveness of the surgical intervention. The study will assess the safety and potential benefits of this combined approach in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates are women over 18 with histologically confirmed advanced ovarian, fallopian tube, or primary peritoneal cancer who have shown a positive response to neoadjuvant chemotherapy.
Not a fit: Patients with distant metastasis or those who do not respond to neoadjuvant chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and quality of life for patients with advanced ovarian cancer.
How similar studies have performed: While HIPEC has been explored in various settings, this specific approach following NACT is novel and has not been extensively tested in this patient population.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New Hyde Park, New York
- Long Island Jewish Medical Center — New Hyde Park, New York, United States (Recruiting)
Study contacts
- Principal investigator: Jill Whyte, MD — Northwell Health
- Study coordinator: Jill S Whyte, MD
- Email: jwhyte@northwell.edu
- Phone: 5165624438
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.