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PIPAC Nab-pac for Stomach, Pancreas, Breast and Ovarian Cancer

NCT03304210 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-11-07

Study results available
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Summary

The PIPAC nab-pac study is designed to examine the maximal tolerated dose of albumin bound nanoparticle paclitaxel (nab-pac, Abraxane) administered with repeated pressurized intraperitoneal aerosol chemotherapy (PIPAC), in a multicentre, multinational phase I trial.

Conditions

  • Peritoneal Carcinomatosis
  • Ovarian Cancer Stage IIIB
  • Ovarian Cancer Stage IIIC
  • Ovarian Cancer Stage IV
  • Breast Cancer Stage IIIB
  • Breast Cancer Stage IIIc
  • Breast Cancer Stage IV
  • Stomach Cancer Stage III
  • Stomach Cancer Stage IV With Metastases
  • Pancreas Cancer, Stage III
  • Pancreas Cancer, Stage IV

Interventions

DRUG

PIPAC with Abraxane

Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.

Sponsors & Collaborators

  • Kom Op Tegen Kanker

    collaborator OTHER

  • University Ghent

    collaborator OTHER

  • Hopital Lariboisière

    collaborator OTHER

  • University Women's Hospital Tübingen

    collaborator OTHER

  • Candiolo Cancer Institute - IRCCS

    collaborator OTHER

  • Centre Hospitalier Universitaire Vaudois

    collaborator OTHER

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Wim P Ceelen, MD, PhD, Prof · University Hospital, Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-16
Primary Completion
2020-05-06
Completion
2020-05-06

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03304210 on ClinicalTrials.gov