Study of Efficacy and Safety of Laparoscopic Intra-abdominal Chemotherapy (PIPAC) Performed in Pa… (NCT02604784) | Clinical Trial Compass
CompletedPhase 1/2
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
Italy105 participantsStarted 2015-10
Plain-language 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.
Who can participate
Age range18 Years – 78 Years
SexALL
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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 ot…
What they're measuring
1
Overall Response Rate (ORR) according to RECIST criteria (version 1.1) after 2 and 3 cycles of PIPAC.