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Phase III

A Phase III Randomized Trial of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Cisplatin Versus no HIPEC at the Time of Optimal Interval Cytoreductive Surgery Followed by Niraparib Maintenance in Patients With Newly Diagnosed Stage III and IV Ovarian, Primary Peritoneal, and Fallopian Tube Cancer (Heated Ovarian Treatment Trial)

  • Study HIC#:2000035431
  • Last Updated:03/03/2024

Patients will be registered prior to, during or at the completion of neoadjuvant chemotherapy (Paclitaxel 175 mg/m2 IV over 3 hours and Carboplatin AUC 6 IV on Day 1 every 21 days for 3-4 cycles). Registered patients who progress during neoadjuvant chemotherapy will not be eligible for iCRS and will be removed from the study.

Following completion of neoadjuvant chemotherapy, interval cytoreductive surgery (iCRS) will be performed in the usual fashion in both arms. Patients will be randomized at the time of iCRS (iCRS must achieve no gross residual disease or no disease >1.0 cm in largest diameter) to receive HIPEC or no HIPEC. Patients randomized to HIPEC (Arm A) will receive a single dose of cisplatin (100mg/m2 IP over 90 minutes at 42 C) as HIPEC. After postoperative recovery patients will receive standard post-operative platinum-based combination chemotherapy. Patients randomized to surgery only (Arm B) will receive postoperative standard chemotherapy after recovery from surgery.

Both groups will receive an additional 2-3 cycles of platinum-based combination chemotherapy per institutional standard (Paclitaxel 175 mg/m2 IV over 3 hours and Carboplatin AUC 6 IV on Day 1 every 21 days for 2-3 cycles) for a maximum total of 6 cycles of chemotherapy (neoadjuvant plus post-operative cycles) followed by niraparib individualized dosing until progression or 36 months (if no evidence of disease).

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    Eligibility Criteria

    Inclusion Criteria:

    1. Patients must have a pathologic diagnosis of high grade serous or endometrioid epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, stage III or IV documented on CT scan/MRI, must be recommended to undergo neoadjuvant chemotherapy (3-4 cycles allowed) and are considered candidates for interval cytoreductive surgery (iCRS) as determined by the enrolling investigator.
    2. Patients with stage IV disease must have complete response of extra-abdominal disease on preoperative imaging (e.g. pleural effusion, mediastinal, inguinal, supraclavicular lymphadenopathy, or other extra-abdominal metastases).
    3. Patient must have no gross residual disease or no disease >1.0 cm in largest diameter following iCRS and prior to randomization.
    4. Patients must have Myriad myChoice HRD test results available prior to registration.
    5. Patient must have adequate bone marrow and organ function:

      Bone marrow function:

      Hemoglobin ≥ 8.5 g/dL. Absolute neutrophil count (ANC) ≥ 1,000/mm3. Platelets ≥ 100,000/mm3.

      Renal function:

      Creatinine ≤ 1.3mg/dl Calculated creatinine clearance (≥ 30 mL/min/1.73 m2) per National Kidney Foundation guidelines and NHANES III

      Hepatic function:

      Bilirubin ≤ 1.5 times ULN. ALT ≤ 3 times the ULN. AST ≤ 3 times the ULN.

      Neurologic function:

      Peripheral neuropathy ≤ CTC AE grade 2.

      Blood coagulation parameters:

      PT with an INR of ≤ 1.5 and a PTT ≤ 1.5 times the ULN. For patients on full-dose oral anti-coagulation (such as warfarin or rivaroxaban), in-range INR (usually between 2 and 3) and a PTT <1.2 times the ULN.

    6. Patients must have a GOG performance status of 0 or 1.
    7. Patient must be age > 18.
    8. Patients must have a life expectancy > 3 months.
    9. Patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to iCRS and must be practicing an effective form of contraception (with failure rate <1% per year) during the study period and for 6 months following the last dose of niraparib. Patients of childbearing potential must consent to pregnancy testing prior to receiving niraparib and monthly thereafter for the duration of the study.

      Patients are considered postmenopausal and not of child-bearing potential if they are free from menses for >1 year or are surgically sterilized.

    10. Patients must have normal blood pressure (BP) or adequately treated and controlled hypertension based on local standard of care (systolic BP < 140 mmHg and diastolic < 90 mmHg)
    11. Patients receiving corticosteroids may continue as long as their dose is stable for at least 4 weeks prior to randomization.
    12. Patients must agree to not donate blood during the study or for 90 days after the last dose of study treatment.
    13. Patients with known human immunodeficiency virus (HIV) are allowed if they meet all of the following criteria:

      1. Cluster of differentiation 4 ≥350/µL and viral load <400 copies/mL
      2. No history of acquired immunodeficiency syndrome-defining opportunistic infections within 12 months prior to randomization
      3. No history of HIV associated malignancy for the past 5 years
      4. Concurrent antiretroviral therapy as per the most current National Institutes of Health (NIH) Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV started >4 weeks prior to randomization.

    Exclusion Criteria:

    1. Patients with low-grade serous, clear cell, mucinous, non-epithelial ovarian cancers and borderline tumors.
    2. Patients who have received prior treatment for ovarian cancer other than the first 3-4 cycles of platinum based neoadjuvant chemotherapy.
    3. Patients not eligible for iCRS based on evidence of progression of disease during neoadjuvant chemotherapy (documented on CT scan/MRI required within 28 days of iCRS).
    4. Patients not eligible to iCRS based on medical co-morbidites as per enrolling investigator.
    5. Patients with stage IV disease without complete response of extra-abdominal disease on preoperative imaging (e.g., pleural effusion, mediastinal, inguinal, supraclavicular lymphadenopathy, or other extra-abdominal metastases) who are not deemed resectable with iCRS.
    6. Patients with a history of Myelodysplastic Syndrome or Acute Myeloid Leukemia.
    7. Patients who are pregnant or lactating.
    8. Patients with a hypersensitivity or allergy to paclitaxel, docetaxel, carboplatin, cisplatin, or niraparib.
    9. Patients with a severe infection requiring IV antibiotics within 2 weeks of planned randomization.
    10. Patients with other uncontrolled, inter-current medical conditions.
    11. Patient with metastatic disease to the central nervous system.
    12. Patient with uncontrolled insulin dependent diabetes (HbA1c greater than or equal to 6%) or pre-existing renal condition.
    13. Patients with pre-existing hearing loss.
    14. Patients with Prior Reversible Encephalopathy Syndrome (PRES).
    15. Patients with current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease per investigator assessment). Severe hepatic impairment patients should be excluded.
    16. Patients with any clinically significant gastrointestinal (GI) abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels.
    17. Patients with clinically significant cardiovascular disease (e.g., significant cardiac conduction abnormalities, uncontrolled hypertension, myocardial infarction, uncontrolled cardiac arrhythmia or unstable angina <6 months prior to randomization, New York Heart Association Grade 2 or greater congestive heart failure, serious cardiac arrhythmia requiring medication, Grade 2 or greater peripheral vascular disease, and history of cerebrovascular accident within 6 months).
    18. Patients with an increased bleeding risk due to concurrent conditions (e.g., major injuries or major surgery within the past 28 days prior to study randomization and/or history of hemorrhagic stroke, transient ischemic attack, subarachnoid hemorrhage, or clinically significant hemorrhage within the past 3 months).
    19. Patients with known active hepatitis B (e.g., hepatitis B surface antigen reactive) are excluded unless their HBV is stably controlled on nucleos(t)ide analogs (e.g. entecavir or tenofovir) which will be continued for the duration of the study. A patient who is HCV Ab positive but HCV RNA negative due to prior treatment or natural resolution should be eligible.
    20. Patient has had investigational therapy administered within 4 weeks or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to study randomization.
    21. Patient has received a live vaccine within 30 days of study randomization. COVID19 vaccines that do not contain live viruses are allowed at any time during study treatment.
    22. Patient has a diagnosis, detection, or treatment of another type of cancer ≤ 2 years prior to randomization (except basal or squamous cell carcinoma of the skin and cervical cancer in situ that has been definitively treated)
    23. Patients who have had radiotherapy encompassing > 20% of the bone marrow within 2 weeks of randomization; or any radiation therapy within 1 week prior to randomization.

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