Using heated chemotherapy with cisplatin for advanced ovarian and fallopian tube cancer treatment
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.
This study is testing a new way to use heated chemotherapy with cisplatin during surgery to see if it helps people with advanced ovarian or fallopian tube cancer feel better and live longer.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT05415709 on ClinicalTrials.gov |
What this trial studies
This early-phase trial evaluates the safety and tolerability of administering intravenous cisplatin before interval cytoreductive surgery, followed by hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin during surgery for patients with stage III or IV ovarian, fallopian tube, or peritoneal cancer. Patients will receive standard chemotherapy before surgery and will be randomized to either receive cisplatin before surgery or during HIPEC. The study aims to assess treatment feasibility, perioperative outcomes, quality of life, and survival rates, while also examining changes to the gut microbiome. Participants will be monitored for side effects and overall health outcomes throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with newly diagnosed stage III or IV epithelial ovarian, fallopian tube, or peritoneal cancer who are planned for or currently receiving neoadjuvant chemotherapy.
Not a fit: Patients with early-stage cancer or those not receiving neoadjuvant chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved tumor control and better survival rates for patients with advanced ovarian and fallopian tube cancers.
How similar studies have performed: Other studies have shown promising results with hyperthermic intraperitoneal chemotherapy, suggesting potential benefits for similar treatment approaches.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 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 Criteria:
* 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
Where this trial is running
Columbus, Ohio
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Floor Backes, MD — Ohio State University Comprehensive Cancer Center
- Study coordinator: The Ohio State University Comprehensive Cancer Center
- Email: OSUCCCClinicaltrials@osumc.edu
- Phone: 800-293-5066
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.