Combining olaparib with cisplatin HIPEC during interval cytoreductive surgery for ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open‑label, single‑center, single‑arm phase I/II trial with a safety lead‑in that combines perioperative olaparib with cisplatin HIPEC during interval cytoreductive surgery. Phase I uses a time‑to‑event Bayesian Optimal Interval (TITE‑BOIN) dose‑finding design testing three olaparib dose levels to identify a recommended phase II dose based on dose‑limiting toxicities and measurements of intra‑tumor and systemic PARP inhibition. Phase II will enroll about 40 patients to characterize the safety profile of the recommended dose and explore proof‑of‑concept efficacy through translational biomarkers and survival outcomes. The intervention aims to exploit hyperthermia‑induced homologous recombination deficiency to enhance local synergy between PARP inhibition and cisplatin without adding systemic platinum toxicity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* In order to be eligible to participate in this study, a subject must meet all of the following criteria:

  * Signed and written informed consent
  * At least 18 years of age and able to understand patients' information
  * FIGO stage III primary high-grade serous ovarian, fallopian tube, or extra-ovarian cancer.
  * FIGO stage IV is allowed in the following situations:

    * Resectable stage IV desease, such as local bowel involvement, iatrogenic abdominal wall metastases or umbilical lesions
    * Stage IV based on cardiophrenic lymph nodes \<1cm
  * The diagnosis should be confirmed with either histology or cytology. If the diagnosis of ovarian carcinoma is based on cytology only, immunohistochemistry, including keratin 7, keratin 20, p53, PAX8 should be considered for confirmation of the diagnosis (at the discretion of the pathologist)
  * Eligible and planned for interval cytoreductive surgery with HIPEC

    * Neo-adjuvant chemotherapy consists of at least 3 courses of carboplatin/paclitaxel
    * Patients should have response or stable disease after NACT; no progression should occur
    * Operability has been evaluated in a multidisciplinary team (MDT) meeting via CT scan, MRI or diagnostic laparoscopy and an optimal or complete interval CRS is deemed feasible
  * Fit for major surgery, WHO performance status 0-2
  * Adequate bone marrow function (hemoglobin level \>5.5 mmol/L, leukocytes \>3 x10\^9/L, platelets \> 100 x10\^9/L)
  * Adequate hepatic function (ALT, AST, and bilirubin \< 2.5 times the upper limit of normal)
  * Adequate renal function (creatinine clearance ≥ 60 ml/min using Cockcroft-Gault formula or 24-hour measurement or ml/min/1,73 m2 using MDRD or CKD-EPI)

Exclusion Criteria:

* A potential subject who meets any of the following criteria will be excluded from participation in this study:

  * History of previous malignancy treated with chemotherapy
  * Opting for fertility-sparing surgery
  * Concurrent use of potent inducers or inhibitors of CYP3A4 as assessed with the KNMP "G-standaard" that cannot be stopped temporarily

Where it's running

• NKI-AvL
  Amsterdam, Netherlands Recruiting

Study contacts

• Study coordinator: madelief schreuder-goedheijt
• Email: m.schreudergoedheijt@nki.nl
• Phone: 0205129111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.