patients with peritoneal carcinomatosis from ovarian, gastric and colorectal cancers and in primary cancers of peritoneum. MedDRA version: 21.1 Level: PT Classification code 10028980 Term: Neoplasm System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: CISPLATINO TEVA ITALIA - 1MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO IN VETRO DA 100 ML
Product Name: cisplatino
Product Code: n.a.
Pharmaceutical Form: Concentrate for sol
Sponsors
FONDAZIONE DEL PIEMONTE PER L'ONCOLOGIA IRCCS
Eligibility
Sex/Gender
All
Inclusion 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: - Extra-abdominal metastatic disease, with the exception of isolated pleural carcinomatosis. - Bowel obstruction. - Chemotherapy or surgery within the last TWO weeks prior to enrollment. - 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. - Prior treatment that reached 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 intercourse or agree to use an effective clinically acceptable method (with failure rate <1%) during the study and during 6 months after the last treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Cohort A: - To evaluate the efficacy of PIPAC according to the Overall Response Rate (ORR) in peritoneal carcinomatosis (CP) from colorectal, ovarian, gastric cancers and primary peritoneal tumors. Cohort B - To determine the maximum tolerated dose of oxaliplatin o cisplatin and doxorubicin by PIPAC - To evaluate safety and tolerability of oxaliplatin o cisplatin and doxorubicin by PIPAC;Secondary Objective: To evaluate the efficacy in terms of overall survival and time to progression and the safety according to the criteria of the CTCAE v. 4.0;Primary end point(s): Overall Response Rate (ORR) according to RECIST criteria (version 1.1);Timepoint(s) of evaluation of this end point: week 10 and 17 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The overall survival (OS); The degree of histological regression assessed by pathological review; - Measurement of clinical tumor response to therapy using FDG- Positron Emission Tomography (PET) according to PERCIST criteria (versione 1.0).; The median time to progression (TTP) according to RECIST criteria (version 1.1) after two or three cycles of PIPAC;Timepoint(s) of evaluation of this end point: 18 months; week 0, 6 and 12; week 11; weeks 10,17 and follow up | — |
Countries
Italy
Contacts
Public ContactDirezione di Chirurgia Oncologica
Fondazione del Piemonte per l'Oncologia
Outcome results
None listed