Intraoperative Intraperitoneal Chemoperfusion to Treat Peritoneal Minimal Residual Disease in Stage III Ovarian Cancer: A Randomized Phase II Trial

AGO/2015/002

The OvIP1 study is designed to examine how drug dose and perfusion temperature affect the pharmacokinetics and pharmacodynamics of cisplatin used as (hyperthermic) intraperitoneal chemoperfusion, as an adjunct to surgery, in women with stage III epithelial ovarian cancer.

2016-03-01

2020-12-31

2021-08-25

Completed

Early phase I

56

Inclusion Criteria: * Tumor type: \* Biopsy proven serous epithelial ovarian carcinoma or peritoneal carcinoma * Primary or recurrent disease * Extent of disease: * Positive retroperitoneal lymph nodes and /or microscopic metastasis beyond the pelvis (FIGO stage III, Appendix (47)) * Stage IV with unilateral pleural fluid allowed * Complete or nearly complete macroscopic cytoreduction at the time of surgery (CC-0 or CC-1) deemed possible based on imaging, laparoscopy, or both * Second-line patients; platinum sensitive * Age over 18 years * No major cardiac or respiratory disease * Adequate performance status (Karnofsky index \> 70%) * Adequate mental faculty, allowing to understand the proposed treatment protocol and provide informed consent * Expected life expectancy more than 6 months * Laboratory data: * Serum creatinine ≤ 1.5 mg/dl or a calculated Glomerular Filtration Rate (GFR) (CKD-EPI) ≥ 60 mL/min/1.73 m2 * Serum total bilirubin ≤ 1.5 mg/dl, except for known Gilbert's disease * Platelet count \> 100.000/µl * Hemoglobin \> 9g/dl * Neutrophil granulocytes \> 1.500/ml * International Normalized Ratio (INR) ≤ 2 * Absence of alcohol and/or drug abuse * No other concurrent malignant disease * No inclusion in other clinical trials interfering with the study protocol * No concurrent chronic systemic immune or hormone therapy, except neoadjuvant chemotherapy * Absence of any severe organ insufficiency * No pregnancy or breast feeding * Written informed consent Exclusion Criteria: * Severe or uncontrolled cardiac insufficiency, including recent (\< 6 months) occurrence of myocardial infarction, the presence of congestive cardiac insufficiency, of symptomatic angor in spite of optimal medical care, of cardiac arrhythmia requiring medical treatment presenting insufficient rhythm control, or uncontrolled arterial hypertension * Pregnancy or breast feeding * Platinum resistant or refractory disease * Active bacterial, viral or fungal infection * Active gastro-duodenal ulcer * Parenchymal liver disease (any stage cirrhosis) * Uncontrolled diabetes mellitus * Severe obstructive or restrictive respiratory insufficiency * Psychiatric pathology capable of affecting comprehension and judgment faculty * Tumor in the presence of obstruction * Evidence of extra-abdominal disease (with the exception of unilateral malignant pleural effusion) or extensive liver metastasis

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 56, 'type': 'ACTUAL'}}

2023-11-27