The purpose of this study is to evaluate the tolerance, safety, efficacy, and pharmacokinetics of pressurized intraperitoneal aerosol chemotherapy (PIPAC) with paclitaxel in patients with platinum-resistant recurrent ovarian cancer and peritoneal carcinomatosis.
Age: Women aged 19-85 years.
Diagnosis: Histologically confirmed ovarian, fallopian tube, or peritoneal cancer.
Refractory: Disease progression during platinum-based chemotherapy.
Resistant: Progression within 6 months (24 weeks) post-platinum therapy.
≥2 distant metastases (excluding retroperitoneal lymph nodes, pleural effusion, and localized skin metastases).
Contraindications to paclitaxel per approved domestic labeling.
Hypersensitivity history to paclitaxel or PIPAC devices.
NYHA Class ≥II heart failure
Sequential
Pressurized intraperitoneal aerosol chemotherapy (PIPAC) using paclitaxel
DrugAll patients enrolled in this study receive PIPAC using paclitaxel under 12 mmHg at 6 weeks intervals (up to 9 cycles) 1. Phase 1 Design 1. Dose Escalation: Standard 3+3 design across 5 paclitaxel cohorts (20 → 40 → 67 → 100 → 140 mg/m²) using modified Fibonacci increments (100%, 67%, 50%, 40%). 2. Maximum tolerated dose(MTD) Determination * If ≥2/6 patients in cohort χ experience dose limiting toxicities(DLTs; Grade ≥3 toxicity per CTCAE v5.0, excluding manageable pain) and ≤1/6 in cohort χ-1, MTD = χ-1. * If no DLTs at 140 mg/m², Phase 1 concludes. 3. Dose Reduction * DLTs in 20 mg/m² trigger de-escalation to 10 mg/m². * If ≤1/6 DLTs in 10 mg/m² → RP2D; ≥2/6 DLTs → trial termination. 2. Phase 2 Design : Evaluates efficacy/safety of PIPAC at the RP2D in 23 patients, adjusting for 5-17% laparoscopic access failure.
Dose limiting toxicities
Dose limiting toxicities
Maximum tolerated dose
We consider dose escalation if 3 consecutive DLTs do not occur, or less than 1 in 6 DLTs occur, per standard 3+3 design. If DLT occurs in 2 or more of 6, the lower dose is considered the MTD if 1 or fewer DLTs are identified. In addition, the highest dose (140 mg/m2) is considered the MTD when 3 to 0 DLTs or 6 to 1 DLTs are identified at the highest dose. On the other hand, if the initial dose (20 mg/m2) is reduced to 10 mg/m2 to account for DLT, it is considered the MTD if no more than 1 in 6 develop DLT at that reduced dose.
Recommended Phase 2 Dose
Recommended Phase 2 Dose determined by dose limiting toxicities
Disease control rate
Disease control rate at the 9-week time point
Maximum concentration (Cmax)
Cmax on pharmacokinetic evaluation of paclitaxel administered via pressurized intraperitoneal aerosol chemotherapy
Time at which Cmax is observed (Tmax)
Tmax on pharmacokinetic evaluation of paclitaxel administered via pressurized intraperitoneal aerosol chemotherapy
Area under the curve (AUC)
AUC on pharmacokinetic evaluation of paclitaxel administered via pressurized intraperitoneal aerosol chemotherapy
Disease control rate
Disease control rate at the 9-week time point
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
