Clinical trial NCT02735928: Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Applied to Platinum-Resistant Recurrence of Ovarian Tumor
Official title: Feasibility, Efficacy and Safety of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) With Cisplatin in Women With Recurrent Ovarian Cancer: an Open-label, Single-arm Phase I-II Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Epithelial Cancer Recurrent
Platinum-resistant
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2016-04-13
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with first recurrent resistance ovarian cancer and disease progression with peritoneal carcinomatosis will undergo PIPAC procedure. The primary end point is to determine the clinical benefit rate (CBR) of a pressurized intraperitoneal aerosol chemotherapy with a combination of cisplatin and doxorubicin.

Detailed description: This study aims to investigate the therapeutic efficacy of PIPAC using cisplatin and doxorubicin in women with first recurrent resistance ovarian cancer and disease progression with peritoneal carcinomatosis. The primary objective of this study is to determine the Clinical Benefit Rate (CBR) according to RECIST/GCOG criteria after three cycles of PIPAC with PIPAC cisplatin and doxorubicin

Eligibility criteria: Inclusion Criteria:

* Patients affected by first or second platinum resistant epithelial ovarian tumor recurrence.
* ECOG-performance status ≤ 3.
* Adequate respiratory, hepatic, cardiac, kidney and bone marrow function (absolute neutrophil count \> 1500 / mm3, platelets \> 150 000/μl, creatinine clearance \> 60 mL / min according to Cockroft formula).
* Patient-compliant and psychologically able to follow the trial procedures.

Exclusion Criteria:

* Non-epithelial ovarian cancer or borderline ovarian tumor.
* Pregnancy or breastfeeding.
* Patients affected by major depressive disorder even in treatment or minor mood disorders.
* Patients with severe impairment of respiratory, hepatic or renal function.
* Patients with cardiac, neurological or metabolic uncontrolled pharmacologically disease
* Patients with bowel obstruction.
* Inadequate bone marrow, liver, kidney function.
* No clear-peritoneal disease at surgical exploration.
* Patients with ascites \>2000 cc (CT-Scan)
* Patients who have already made third line chemotherapy.

Primary outcomes:
measure: Clinical Benefit Rate (CBR) according to RECIST/GCOG criteria after three cycles of PIPAC with PIPAC cisplatin and doxorubicin
timeFrame: 12-18 weeks
Secondary outcomes:
measure: The median time to progression according to RECIST criteria after three cycles of PIPAC with cisplatin
timeFrame: 1 Year
measure: Fagotti score, as assessed by laparoscopy
timeFrame: 1 Year
measure: The degree of histological regression assessed by pathological review of repeated peritoneal biopsies
timeFrame: 1 Year
measure: The proportion of women with a reduction of serum CA-125 of at least 50% after PIPAC
timeFrame: 1 Year
measure: Evaluation of the Quality Of Life (QOL) on the basis of the European Organization for Research and Treatment of Cancer (EORTC) QOL questionnaires
timeFrame: 1 year
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Catholic University of Sacred Heart
Study officials:
References:
citation: Fagotti A, Petrillo M, Costantini B, Fanfani F, Gallotta V, Chiantera V, Turco LC, Bottoni C, Scambia G. Minimally invasive secondary cytoreduction plus HIPEC for recurrent ovarian cancer: a case series. Gynecol Oncol. 2014 Feb;132(2):303-6. doi: 10.1016/j.ygyno.2013.12.028. Epub 2013 Dec 27.
citation: Tempfer CB, Winnekendonk G, Solass W, Horvat R, Giger-Pabst U, Zieren J, Rezniczek GA, Reymond MA. Pressurized intraperitoneal aerosol chemotherapy in women with recurrent ovarian cancer: A phase 2 study. Gynecol Oncol. 2015 May;137(2):223-8. doi: 10.1016/j.ygyno.2015.02.009. Epub 2015 Feb 18.
citation: Vizzielli G, Costantini B, Tortorella L, Petrillo M, Fanfani F, Chiantera V, Ercoli A, Iodice R, Scambia G, Fagotti A. Influence of intraperitoneal dissemination assessed by laparoscopy on prognosis of advanced ovarian cancer: an exploratory analysis of a single-institution experience. Ann Surg Oncol. 2014 Nov;21(12):3970-7. doi: 10.1245/s10434-014-3783-6. Epub 2014 May 22.