Clinical trial NCT02604784: Study of Efficacy and Safety of Laparoscopic Intra-abdominal Chemotherapy (PIPAC) Performed in Patients With Peritoneal Carcinomatosis From Colorectal, Ovarian, Gastric Cancer and Primary Peritoneal Tumors
Official title: Feasibility, Efficacy and Safety of Pressurized IntraPeritoneal Air-flow Chemotherapy (PIPAC) With Oxaliplatin, Cisplatin and Doxorubicin in Patients With Peritoneal Carcinomatosis From Colorectal, Ovarian, Gastric Cancers and Primary Tumors of the Peritoneum: An Open-label, Two-arms, Phase I-II Clinical Trial. PI-CaP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Peritoneal Carcinomatosis
Keywords: Pressurized Intra Peritoneal Air-flow Chemotherapy (PIPAC)
Chemotherapy
Peritoneal Carcinomatosis
Lead sponsor: Fondazione del Piemonte per l'Oncologia
Sponsor class: OTHER
First posted: 2015-11-13
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two parallel cohorts according to patients characteristics Patient with indication for systemic standard chemotherapy will be accrued in Cohort A (for a Phase II repeated single dose PIPAC).

Patient with no indication for sistemic standard chemotheralpy will be accrued in Cohort B ( for a Phase, single ascending dose PIPAC)
Primary purpose: TREATMENT

Brief summary: Single center, open label, phase I-II, non-randomized, two-cohort, repeated single dose study to explore the feasibility, efficacy, safety, and Overall Response Rate (ORR) of oxaliplatin, or cisplatin and doxorubicin when given as a pressurized intraperitoneal chemotherapy (PIPAC) to patients (men and women) with peritoneal carcinomatosis from ovarian, gastric and colorectal cancers and in primary cancers of peritoneum.


Eligibility criteria: Inclusion Criteria:

* Clinical and pathological confirmation of peritoneal carcinomatosis from gastric, colorectal and ovarian cancers or primary peritoneal tumors.
* Patients aged between 18 and 78 years.
* Performance status sec. ECOG ≤ 2
* Disease progression/relapse after at least one line of previous i.v. standard chemotherapy in gastric cancer and primary peritoneal tumors and two lines in colorectal and ovarian cancers.
* Patients with peritoneal carcinomatosis from ovarian, gastric and colorectal cancers and primary peritoneal cancers not eligible to cytoreductive surgery +/- HIPEC.
* Blood and electrolyte counts, liver, renal and cardiopulmonary function parameters within 10% of the normal range.
* Written informed consent.
* Tumor mass present on CT-scan in order to allow tumor response assessment with RECIST-criteria.

Exclusion Criteria:

* Extra-abdominal metastatic disease, with the exception of isolated pleural carcinomatosis.
* Bowel obstruction.
* Severe renal impairment, myelosuppression, severe hepatic impairment, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias.
* Immunocompromised patients such as those with an immunosuppressive medication or a known disease of the immune system.
* Creatinine clearance \< 60 ml /min.
* Pregnancy.
* Previous treatment reaching the maximum cumulative dose of doxorubicin, daunorubicin, epirubicin, idarubicin and/or other anthracyclines and anthracenediones.
* Known allergy to cisplatin or other platinum-containing compounds or to doxorubicin.
* Patients of both sexes who do not conduct complete abstinence from heterosexual relationships or agree to use an effective clinically acceptable method (with failure rate \<1%) during the study and the following 6 months after the last treatment.

Primary outcomes:
measure: Overall Response Rate (ORR) according to RECIST criteria (version 1.1) after 2 and 3 cycles of PIPAC.
timeFrame: 18 weeks
Secondary outcomes:
measure: The overall survival (OS)
timeFrame: 30 months
measure: The degree of histological regression assessed by pathological review
timeFrame: 18 weeks
measure: The median time to progression (TTP) according to RECIST criteria (version 1.1) after two or three cycles of PIPAC
timeFrame: 30 months
measure: Measurement of clinical tumor response to therapy using FDG- Positron Emission Tomography (PET) according to PERCIST criteria (version 1.0).
timeFrame: 22 weeks
measure: The Peritoneal Carcinomatosis Index (PCI) before and after therapy
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Candiolo
country: Italy
facility: Department of Surgical Oncology - FPO-IRCCS Institute for Cancer Research and Treatment
state: Turin
Study officials:
References:
citation: Robella M, Berchialla P, Borsano A, Cinquegrana A, Ilari Civit A, De Simone M, Vaira M. Study Protocol: Phase I Dose Escalation Study of Oxaliplatin, Cisplatin and Doxorubicin Applied as PIPAC in Patients with Peritoneal Metastases. Int J Environ Res Public Health. 2021 May 25;18(11):5656. doi: 10.3390/ijerph18115656.