Status:
RECRUITING
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
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Conditions:
Fallopian Tube Endometrioid Adenocarcinoma
Fallopian Tube Mucinous Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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, fal...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the safety and tolerability of intravenous (IV) cisplatin on the day prior to interval cytoreductive surgery (CRS) to administration of hyperthermic intraepithelial...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05415709
Start Date
June 13 2022
End Date
December 31 2026
Last Update
February 14 2025
Active Locations (1)
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1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210