Tolerance, Safety, Efficacy, and Pharmacokinetics of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Using Paclitaxel for Platinum-resistant Recurrent Ovarian Cancer

NCT07273396 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: PIPAC-OVPAC-1/2a
• Study Type: interventional
• Target: 53
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Ovarian Neoplasms; Peritoneal Neoplasms

Keywords

Pressurized intraperitoneal aerosol chemotherapy; platinum-resistant recurrent; ovarian cancer; paclitaxel

Outcome Measures

Primary Outcomes (4)

• Dose limiting toxicities

  Dose limiting toxicities

  Till 6 weeks after the first PIPAC in phase 1 study

• 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.

  During phase 1 study (up to 6 weeks)

• Recommended Phase 2 Dose

  Recommended Phase 2 Dose determined by dose limiting toxicities

  During phase 1 study

• Disease control rate

  Disease control rate at the 9-week time point

  During phase 2 study

Secondary Outcomes (15)

• Maximum concentration (Cmax)

  During phase 1 study

• Time at which Cmax is observed (Tmax)

  During phase 1 study

• Area under the curve (AUC)

  During phase 1 study

• Disease control rate

  During phase 1 study

• Progression-free survival

  During phase 1 and 2a studies

Study Arms (1)

PIPAC-OVPAC group

EXPERIMENTAL

Drug: Pressurized intraperitoneal aerosol chemotherapy (PIPAC) using paclitaxel

Interventions

Pressurized intraperitoneal aerosol chemotherapy (PIPAC) using paclitaxel DRUG

All 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.

PIPAC-OVPAC group

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: Women aged 19-85 years.
• Diagnosis: Histologically confirmed ovarian, fallopian tube, or peritoneal cancer.
• Platinum Status:
• Refractory: Disease progression during platinum-based chemotherapy.
• Resistant: Progression within 6 months (24 weeks) post-platinum therapy.
• Prior Therapies: ≥2 prior intravenous chemotherapies (may include paclitaxel).
• Treatment Options: Unresponsive to/ineligible for standard therapies (e.g., intolerance, hypersensitivity) and ineligible for surgical resection.
• Measurable Disease: ≥1 measurable/evaluable peritoneal lesion per RECIST 1.1.
• Metastasis: ≤1 asymptomatic distant metastasis (excluding retroperitoneal lymph nodes, pleural effusion, localized skin metastases).
• Imaging Confirmation: Peritoneal carcinomatosis confirmed by PET-CT/CT.
• Performance Status: ECOG 0-2.
• Pregnancy/Contraception:
• Non-pregnant/non-lactating.
• Contraception: Effective methods (IUD, sterilization) for 6 months post-PIPAC (childbearing potential only).
• Organ Function:

You may not qualify if:

• ≥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.
• Uncontrolled comorbidities per investigator judgment:
• NYHA Class ≥II heart failure
• Clinically significant cardiovascular disease (e.g., arrhythmia, myocardial infarction)
• Immunosuppressive conditions (AIDS, autoimmune diseases, immunosuppressive therapy)
• Active HBV/HCV infection
• Uncontrolled hypertension (systolic \>160 mmHg or diastolic \>100 mmHg)
• Uncontrolled diabetes (HbA1c \>8%)
• Radiographic/clinical bowel obstruction.
• IV chemotherapy within 4 weeks prior to Cycle 1 PIPAC.
• Life expectancy \<3 months.
• Prior PIPAC therapy.
• Medically unfit for general anesthesia or laparoscopic surgery.

Sponsors & Collaborators

• Seoul National University Hospital: lead

MeSH Terms

Conditions

Ovarian Neoplasms; Peritoneal Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Abdominal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Study Officials

• Hee Seung Kim, MD, PhD

  Seoul National University College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hee Seung Kim, MD, PhD

CONTACT

82-02-2072-4863; bboddi0311@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: December 9, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): August 31, 2030
• Last Updated: December 9, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share