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RecruitingInterventionalEarly Phase 1

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.

NCT ID: NCT05415709Sponsor: Ohio State University Comprehensive Cancer CenterLast updated: 2026-02-11

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.

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 chemotherapy (HIPEC) with cisplatin at the completion of interval cytoreductive surgery. SECONDARY OBJECTIVES: I. Feasibility of each of the treatment options. II. Treatment delays. III. Perioperative outcomes. IV. Quality of life/patient reported outcomes. V. Recurrence free survival (RFS) and overall survival (OS). VI. Changes to the gut MIcrobiome OUTLINE: Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 3 weeks for 3-4 cycles in the absence of disease progression or unacceptable toxicity. Within 3-4 weeks following the third or fourth neoadjuvant cycle, patients who achieve complete or partial response undergo interval debulking surgery Patients are randomized to 1 of 2 arms. ARM I: Patients receive cisplatin IV the day prior to interval cytoreductive surgery ARM II: Patients undergo HIPEC and receive cisplatin IV over 90 minutes at the time of interval cytoreductive surgery All patients undergo stool sample collection and diagnostic imaging throughout the trial. After completion of study treatment, patients are followed up for up to 30 days.

Arms & interventions

  • DrugCarboplatin

    Given IV

  • DrugCisplatin

    Given IV

  • ProcedureCytoreductive Surgery

    Undergo CRS

  • DrugHyperthermic Intraperitoneal Chemotherapy

    Undergo HIPEC

  • DrugPaclitaxel

    Given IV

  • OtherQuality-of-Life Assessment

    Ancillary studies

  • OtherQuestionnaire Administration

    Ancillary studies

  • ProcedureBiospecimen Collection

    Undergo stool sample collection

  • ProcedureDiagnostic Imaging

    Undergo diagnostic imaging

Outcome measures

Primary

  • Incidence of chemotherapy-related adverse events

    Defined by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.

    Time frame: 30 days from perioperative treatment

Secondary

  • Feasibility of chemotherapy immediately perioperatively

    Time frame: 1 Day prior to surgery and 1 day of surgery

  • Percentage of patients in Arm C with a treatment free interval of < 8 weeks

    Time frame: Up to 1 year

  • Recurrence free survival

    Time frame: For 3-5 years after study

  • Tumor response

    Time frame: Up to 1 year

  • Quality of life (QOL) assessment EORTC QLQ-C30

    Time frame: Baseline up to 6 months post-treatment

  • Changes to the gut microbiome

    Time frame: Within one week of re-operative appointment, cycle 1 (each cycle is 28 days) of adjuvant chemotherapy and last cycle of adjuvant chemotherapy

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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

Study locations (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

Recruiting
Floor Backes, MD · Contact
Floor Backes, MD · Principal Investigator