OncoMatch/Clinical Trials/NCT04811703
Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Associated With Systemic Chemotherapy in Women With Advanced Ovarian Cancer
Is NCT04811703 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Combined PIPAC / IV chemotherapy treatment for metastatic ovarian carcinoma.
Treatment: Combined PIPAC / IV chemotherapy treatment — Women with history of tumor response insufficient to allow complete cytoreductive surgery after three cycles of previous neoadjuvant systemic carboplatin-paclitaxel chemotherapy will be prospectively recruited in this trial. After signed consent and if unresectability is confirmed, patients will undergo three cycles of doxorubicin-cisplatin PIPAC chemotherapy associated with systemic carboplatin-paclitaxel chemotherapy (alternating PIPAC and intravenous chemotherapy sessions over 3 cycles of 4 weeks). The primary objective of the study is to determine the maximum tolerated dose (MDT). During cycle 1, limiting dose toxicity must be collected as soon as it is known. Each patients will be treated at the dose recommended by the CRM (Continual Reassessment Method ) algorithm conditional on dose-limiting toxicity during Cycle 1. The dose escalation will be guided by CRM to determine the recommended dose of PIPAC chemotherapy for phase II trial. Secondary objectives are : * to evaluate the anatomopathological response, the radiologic tumoral response and the evolution of the peritoneal cancer extent, to the combined chemotherapy * to describe the pharmacokinetic of the PIPAC chemotherapy * to investigate the KELIM parameter as a predictive marker in the response sensitivity of the combined chemotherapy treatment * and to evaluate the safety of the combined chemotherapy. During the first day of the first cycle, blood samples will be collected to measure doxorubicin and cisplatin (pharmacokinetic study). Along these 3 cycles, the dose of antigen CA-125 will be performed before each chemotherapies (intraperitoneal or intravenous). At the end of combined chemotherapy treatment, patients will undergo radiologic tumoral response by imaging assessment (scanner or MRI) and a last dosage of CA-125 will be realized.. In case of a complete / partial response / stabilization (RECIST criteria v.1.) on the imaging, re-evaluation for resectability will be done. If resectable disease, cytoreductive surgery will be programmed and a post-operative visit 1 month later will be realized. Otherwise for patients with progress disease or unresectable the participation in the study will be finished.
Check if I qualifyExtracted eligibility criteria
Cancer type
Ovarian Cancer
Tumor Agnostic
Disease stage
Required: Stage IIB, IIC, III, IV, IVA (FIGO)
Metastatic disease required
Epithelial stage IIb to IVa carcinoma of the ovary, fallopian tubes, or peritoneum ... stage III or IV of the FIGO classification
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: carboplatin-paclitaxel chemotherapy (carboplatin, paclitaxel) — neoadjuvant
history of insufficient tumor response/ after three cycles of previous neoadjuvant systemic carboplatin-paclitaxel chemotherapy as judged by the investigators
Lab requirements
Blood counts
Absolute Neutrophil Count > 1500 / mm3 (or 1.5 10 9/L), Hemoglobin ≥ 9.0 g/dL, platelets > 100 G/L
Kidney function
Serum creatinine ≤1.5 times upper normal values or glomerular filtration rate ≥ 60 mL/min/1.73 m2 estimated by the CKD-EPI equation
Liver function
Total bilirubin ≤1.5 times the upper normal limit, ASAT / ALAT ≤1.5 times the upper normal limit (≤5 times upper normal limits for patients with liver metastases)
Cardiac function
Absence of unstable pathologies: myocardial infarction within 6 months prior to the start of the study, congestive heart failure, unstable angina, active cardiomyopathy, unstable rhythm disorder, uncontrolled hypertension
Adequate hematologic function ... Adequate hepatic and renal function ... Absence of unstable pathologies : myocardial infarction within 6 months prior to the start of the study, congestive heart failure, unstable angina, active cardiomyopathy, unstable rhythm disorder, uncontrolled hypertension
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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