Treating Peritoneal Carcinomatosis With PIPAC

NCT02320448 | Completed Phase 2 DMC

• 1 other identifier: PIPAC
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This is a feasibility study that aims to evaluate whether PIPAC (Pressurized Intraperitoneal Aerosol Chemotherapy) is a safe and feasible treatment in Danish patients with peritoneal cancer.

Conditions

Peritoneal Carcinomatosis

Outcome Measures

Primary Outcomes (1)

• Number of Patients with Adverse Events.

  No patients with adverse events above grade 3 on the CTCAE (Version 4) scale. No patients with complications above grade 2 on the Dindo-Clavien classification.

  5 months.

Secondary Outcomes (2)

• Occupational health.

  5 months.

• Feasibility: Completion of procedure in 28:35

  5 months.

Study Arms (1)

PIPAC

EXPERIMENTAL

PIPAC with cisplatin (7.5mg/m2 in 150 ml saline) and doxorubicin (1.5mg/m2 in 50 ml saline) in patients with peritoneal metastases (PM) from any origin besides colorectal/appendiceal cancers in whom oxaliplatin (92mg/m2 in 150 ml dextrose) will be used. The aerosolised chemotherapy will be nebulized at a flow of 0.5ml/min at a maximum pressure of 200 PSI during a standard laparoscopy with an intraabdominal pressure of 12mmHg. The CO2 will be evacuated 30 minutes after administration of chemotherapy and the patient is closed similar to a standard laparoscopy.

Drug: PIPAC

Interventions

PIPAC DRUG

Also known as: Cisplatin, Doxorubicin, Oxaliplatin

PIPAC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological or cytological verified malignancy.
• Clinical or radiological evidence of peritoneal carcinomatosis.
• No indication for standard chemotherapy.
• Performance status 0-2 and life expectancy of more than 3 months.
• Age \> 18 years.
• Written informed consent must be obtained according to the local Ethics Committee requirements.

You may not qualify if:

• Symptomatic small bowel obstruction (Total parenteral nutrition, nasogastric tube).
• Previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones.
• A history of allergic reaction to cisplatin or other platinum containing compounds or doxorubicin.
• Renal impairment, defined as GFR \< 50 ml/min, (Cockcroft-Gault Equation).
• Myocardial insufficiency, defined as NYHA class \> 2.
• Impaired liver function defined as bilirubin ≥ 1,5 x UNL (upper normal limit).
• Inadequate haematological function defined as ANC ≤ 1.5 x 109/l and platelets ≤ 100 x 109/l.
• Any other condition or therapy, which in the investigator's opinion may pose a risk to the patient or interfere with the study objectives.
• Previous intraabdominal chemotherapy or intraabdominal antibody therapy.

Sponsors & Collaborators

• Michael Bau Mortensen: lead

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (11)

• Sugarbaker PH. Intraperitoneal chemotherapy and cytoreductive surgery for the prevention and treatment of peritoneal carcinomatosis and sarcomatosis. Semin Surg Oncol. 1998 Apr-May;14(3):254-61. doi: 10.1002/(sici)1098-2388(199804/05)14:33.0.co;2-u.

  PMID: 9548609 BACKGROUND

• Coccolini F, Gheza F, Lotti M, Virzi S, Iusco D, Ghermandi C, Melotti R, Baiocchi G, Giulini SM, Ansaloni L, Catena F. Peritoneal carcinomatosis. World J Gastroenterol. 2013 Nov 7;19(41):6979-94. doi: 10.3748/wjg.v19.i41.6979.

  PMID: 24222942 BACKGROUND

• Flessner MF. The transport barrier in intraperitoneal therapy. Am J Physiol Renal Physiol. 2005 Mar;288(3):F433-42. doi: 10.1152/ajprenal.00313.2004.

  PMID: 15692055 BACKGROUND

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

• Jacquet P, Stuart OA, Chang D, Sugarbaker PH. Effects of intra-abdominal pressure on pharmacokinetics and tissue distribution of doxorubicin after intraperitoneal administration. Anticancer Drugs. 1996 Jul;7(5):596-603. doi: 10.1097/00001813-199607000-00016.

  PMID: 8862729 RESULT

• Tempfer CB, Celik I, Solass W, Buerkle B, Pabst UG, Zieren J, Strumberg D, Reymond MA. Activity of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) with cisplatin and doxorubicin in women with recurrent, platinum-resistant ovarian cancer: preliminary clinical experience. Gynecol Oncol. 2014 Feb;132(2):307-11. doi: 10.1016/j.ygyno.2013.11.022. Epub 2013 Nov 23.

  PMID: 24275155 RESULT

• Solass W, Kerb R, Murdter T, Giger-Pabst U, Strumberg D, Tempfer C, Zieren J, Schwab M, Reymond MA. Intraperitoneal chemotherapy of peritoneal carcinomatosis using pressurized aerosol as an alternative to liquid solution: first evidence for efficacy. Ann Surg Oncol. 2014 Feb;21(2):553-9. doi: 10.1245/s10434-013-3213-1. Epub 2013 Sep 5.

  PMID: 24006094 RESULT

• Blanco A, Giger-Pabst U, Solass W, Zieren J, Reymond MA. Renal and hepatic toxicities after pressurized intraperitoneal aerosol chemotherapy (PIPAC). Ann Surg Oncol. 2013 Jul;20(7):2311-6. doi: 10.1245/s10434-012-2840-2. Epub 2013 Feb 3.

  PMID: 23377563 RESULT

• Solass W, Giger-Pabst U, Zieren J, Reymond MA. Pressurized intraperitoneal aerosol chemotherapy (PIPAC): occupational health and safety aspects. Ann Surg Oncol. 2013 Oct;20(11):3504-11. doi: 10.1245/s10434-013-3039-x. Epub 2013 Jun 14.

  PMID: 23765417 RESULT

• Graversen M, Fristrup C, Kristensen TK, Larsen TR, Pfeiffer P, Mortensen MB, Detlefsen S. Detection of free intraperitoneal tumour cells in peritoneal lavage fluid from patients with peritoneal metastasis before and after treatment with pressurised intraperitoneal aerosol chemotherapy (PIPAC). J Clin Pathol. 2019 May;72(5):368-372. doi: 10.1136/jclinpath-2018-205683. Epub 2019 Feb 12.

  PMID: 30755498 DERIVED

• Graversen M, Detlefsen S, Bjerregaard JK, Fristrup CW, Pfeiffer P, Mortensen MB. Prospective, single-center implementation and response evaluation of pressurized intraperitoneal aerosol chemotherapy (PIPAC) for peritoneal metastasis. Ther Adv Med Oncol. 2018 Jun 1;10:1758835918777036. doi: 10.1177/1758835918777036. eCollection 2018.

  PMID: 29899763 DERIVED

MeSH Terms

Conditions

Peritoneal Neoplasms

Interventions

Cisplatin; Doxorubicin; Oxaliplatin

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Coordination Complexes

Study Officials

• Michael Mortensen, Professor

  Odense University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 19, 2014
• Study Start: March 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: September 12, 2017

Record last verified: 2017-09

Locations

DK (1)