Hyperthermic Intraperitoneal Chemotherapy With Cisplatin During Surgery or Cisplatin Before Surgery for the Treatment of Stage III or IV Ovarian, Fallopian Tube or Peritoneal Cancer
Randomized Phase I Study Assessing the Safety and Tolerability Hyperthermic Intraperitoneal Chemotherapy (HIPEC) at Completion of Interval Cytoreductive Surgery Compared to Surgery and Chemotherapy Prior to Surgery for Patients With Stage III/IV Ovarian Cancer Undergoing Neoadjuvant Chemotherapy.
Ohio State University Comprehensive Cancer Center
45 participants
Jun 13, 2022
INTERVENTIONAL
Conditions
Summary
This phase I trial studies the side effects of hyperthermic intraepithelial chemotherapy with cisplatin after surgery or cisplatin before surgery in treating patients with stage III or IV ovarian, fallopian tube or peritoneal cancer receiving chemotherapy before surgery. Hyperthermic intraepithelial chemotherapy involves the infusion of heated cytotoxic chemotherapy that circulates into the abdominal cavity at the time of surgery. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving hyperthermic intraepithelial chemotherapy with cisplatin after surgery or cisplatin before surgery may kill more tumor cells compared to usual care.
Eligibility
Inclusion Criteria23
- Ability to understand (English-speaking), and willingness to sign a written, informed consent
- Age \> 18 years old
- Newly diagnosed stage III or IV epithelial (serous, mucinous, or endometrioid) ovarian, fallopian tube or peritoneal cancer diagnosed by:
- Biopsy/histology (either by interventional radiology or laparoscopy) OR
- Cytology; If diagnosis is based on cytology the following criteria must be met:
- Immunohistochemistry on the block from cytology to demonstrate Mullerian origin
- Presence of pelvic mass AND CA 125 \> 200kU/I AND CA125/CEA ratio \> 25 at initial diagnosis
- Omental cake or other metastases larger than 2 cm in the upper abdomen and/or regional lymph node metastasis irrespective of size (diagnosed by computed tomography \[CT\]/magnetic resonance imaging \[MRI\], ultrasound, or laparoscopy)
- Patient planned for or currently receiving neoadjuvant chemotherapy due to the fact that optimal primary CRS was determined not to be feasible by the primary surgeon
- Patient must be planned or scheduled to undergo interval cytoreductive surgery after cycle 3-4 of neoadjuvant surgery
- Completion of three cycles of neoadjuvant chemotherapy (NACT) with standard therapy (carboplatin \[area under the curve (AUC) 5-6\] day \[D\]1 + paclitaxel \[175 mg/m\^2\] D1 every 3 weeks)
- Following 3-4 cycles of NACT partial or complete response
- Following 3-4 cycles of NACT at least 50% decrease in CA-125 level between pre-cycle 1 and post-cycle 3/prior to surgery
- Fit for major surgery, American Society of Anesthesiologists (ASA )1 or ASA 2
- Eastern Cooperative Oncology Group (ECOG) performance-status score of 0-2
- Serum creatinine \< 1.4 mg/dL
- Creatinine clearance \> 60 ml/min (Cockcroft-Gault formula)
- White blood cell count \> 3.5 x 10\^9 cells/L
- Absolute neutrophil count \> 1.5 kg/ul
- Platelets \> 100,000/ul
- Total bilirubin within 1.5 x normal institutional limits
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x institutional upper limit of normal
- For quality of life assessment, baseline questionnaires should be filled in before randomization
Exclusion Criteria6
- History of breast cancer or previous malignancy within 5 years prior to inclusion, with the exception of radically excised basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- Low grade serious carcinoma of the ovary or borderline ovarian tumors
- History or current diagnosis of inflammatory bowel disease
- History of allergic reactions to compounds of similar chemical or biologic composition to cisplatin, carboplatin, and paclitaxel
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia
- Patients in whom an optimal or complete cytoreduction cannot be performed will be excluded at the time of surgery and be replaced
Interventions
Given IV
Given IV
Undergo CRS
Undergo HIPEC
Given IV
Ancillary studies
Ancillary studies
Undergo stool sample collection
Undergo diagnostic imaging
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05415709