None listed
Conditions
Interventions
Drug, Medical Device : 1. Phase I Study
1) Primar objective
: To determine the maximum tolerated dose and recommended phase II dose of pressurized intraperitoneal aerosol chemotherapy treatment with
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women aged 19–85 years. 2. Histologically confirmed ovarian, fallopian tube, or peritoneal cancer. 3. Platinum-refractory/resistant: - Refractory: Disease progression during platinum-based chemotherapy. - Resistant: Disease progression within 6 months (24 weeks) after completing platinum-based therapy. 4. Received =2 prior intravenous chemotherapies (may include paclitaxel). 5. Unresponsive to/ineligible for standard therapies (e.g., intolerance, hypersensitivity) and ineligible for surgical resection. 6. =1 measurable/evaluable peritoneal lesion per RECIST 1.1. 7. =1 asymptomatic distant metastasis without functional impairment. 8. Peritoneal carcinomatosis confirmed by imaging (PET-CT/CT). 9. ECOG performance status 0–2. 10. Not pregnant (likely to become pregnant, planning to become pregnant) or nursing ? Non-childbearing women, women who are not pregnant or nursing, and women who do not plan to become pregnant during the study ? If a woman of childbearing potential, a negative pregnancy test during screening and immediately prior to PIPAC administration, and agree to adhere to effective contraception as required by this protocol for 6 months (24 weeks) after the last dose of PIPAC. 11. Screening tests confirm adequate bone marrow, hepatic, renal, pulmonary, and coagulation function by meeting all of the following criteria: ? Bone marrow function: absolute neutrophil count > 1,500/mm3, platelet count > 100,000/mm3, hemoglobin > 8.0 g/dL, ? Hepatic function: serum bilirubin 60 mL/min. 5 times the upper limit of normal for serum aspartate transaminase and alanine transaminase ? Renal function: serum creatinine less than or equal to 1.5 times the upper limit of normal, creatinine clearance greater than or equal to 60 mL/min ? Pulmonary function: pulmonary function tests show FVC (forced vital capacity) and FEV1 (forced expiratory volume in 1 second) greater than or equal to 70% of the normal predicted ? Coagulation: INR less than or equal to 1.5 times the upper limit of normal for aPTT 12. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. =2 distant metastases (excluding retroperitoneal lymph nodes, pleural effusion, localized skin metastases). 2. Contraindications to paclitaxel per approved labeling. 3. Hypersensitivity history to paclitaxel or pressurized intraperitoneal aerosol chemotherapy devices. 4. Uncontrolled comorbidities per investigator judgment: - New York Heart Association Class =II heart failure - Clinically significant cardiovascular disease (arrhythmia, myocardial infarction) - Immunosuppressive conditions (acuqied immune deficiency syndrome, autoimmune diseases, immunosuppressive therapy) or autoimmune disease (such as rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, connective tissue disease, etc. - Active hepatitis B or C viral infection - Uncontrolled hypertension (systolic >160 mmHg/diastolic >100 mmHg) - Uncontrolled diabetes (HbA1c >8%) - Radiographic/clinical bowel obstruction. 5. IV chemotherapy within 4 weeks prior to Cycle 1 pressurized intraperitoneal aerosol chemotherapy. 6. Life expectancy <3 months. 7. Prior pressurized intraperitoneal aerosol chemotherapy. 8. Medically unfit for general anesthesia/laparoscopic surgery. 9. Refusal of contraception: - Intrauterine device (<1% failure) - Surgical sterilization (tubal ligation, hysterectomy, vasectomy; <0.5% failure). 10. Participation in another clinical trial within 1 month. 11. Other exclusionary factors per investigator discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The maximum tolerated dose and recommended phase 2 dose based on dose-limiting toxicities observed during the first cycle (6 weeks) of pressurized intraperitoneal aerosol chemotherapy using paclitaxel;the Disease Control Rate at 9 weeks following pressurized intraperitoneal aerosol chemotherapy with paclitaxel | — |
Secondary
| Measure | Time frame |
|---|---|
| The pharmacokinetics of paclitaxel administered via PIPAC;the Disease Control Rate at 9 weeks following pressurized intraperitoneal aerosol chemotherapy with paclitaxel; Progression-free survival up to 72 weeks following pressurized intraperitoneal aerosol chemotherapy with paclitaxel;Overall survival up to 72 weeks following pressurized intraperitoneal aerosol chemotherapy with paclitaxel;Peritoneal cancer index;Peritoneal regression grading score;Changes in ascites;Changes in tumor markers with cancer antigen 125 and human epididymis protein 4;Assessment in quality of life using European Oragnisation for Research and Treatment of Cancer-Quality of Life Questionnaire-C30 and -OV2;Safety evaluation of pressurized intraperitoneal aerosol chemotherapy with paclitaxel;Overall survival up to 72 weeks following pressurized intraperitoneal aerosol chemotherapy with paclitaxel;Progression-free survival up to 72 weeks following pressurized intraperitoneal aerosol chemotherapy with paclitaxel;Peritoneal cancer index;Peritoneal regression grading score;Changes in ascites;Changes in tumor markers with cancer antigen 125 and human epididymis protein 4;Assessment in quality of life using European Oragnisation for Research and Treatment of Cancer-Quality of Life Questionnaire-C30 and -OV2;Safety evaluation of pressurized intraperitoneal aerosol chemotherapy with paclitaxel | — |
Countries
Korea, Republic of
Contacts
Public ContactHee Seung Kim
Seoul National University Hospital
Outcome results
None listed