Treatment of Gastric Peritoneal Carcinomatosis by Association of Complete Surgical Resection of the Lesions and Intraperitoneal Immunotherapy Using Catumaxomab (IIPOP)

January 25, 2017 updated by: Gustave Roussy, Cancer Campus, Grand Paris

Treatment of Gastric Peritoneal Carcinomatosis by Association of Complete Surgical Resection of the Lesions and Intraperitoneal Immunotherapy Using Catumaxomab. A Randomized Phase II Trial.

Treatment by association of complete surgical excision of the lesions and intraperitoneal immunotherapy using Catumaxomab for patients with gastric peritoneal carcinomatosis

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Val de Marne
      • Villejuif, Val de Marne, France, 94805
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • consent form signed
  • Age >= 18
  • Carcinomatosis pre operative known or discivered in intraoperative
  • Patients uin good general condition who may have extent surgery associated to specific inflammatory syndrom of immunotherapy
  • Patients in good general condition
  • Patient insured to social care

Inclusion Criteria (intraoperative):

  • Gastric adenocarcinoma with macroscopic peritoneal carcinomatosis (PC) confirmed by extemporaneous histological examination
  • CP extension minimal or moderate (peritoneal index ≤ 12).
  • Resection of the entire macroscopic lesions detectable (primary tumor, lymph nodes and CP). cleaning D2 lymph node (or D1.5).

Exclusion Criteria:

  • Presence of metastasis in reach
  • Previous treatment with a non-humanized monoclonal AC- (mice or rat)
  • Hypersensitivity to any type of antibody.
  • History of cancer within 5 years preceding the entry in the trial other than basal cell skin carcinoma or in situ of the cervix,
  • Patients already included in another clinical trial with experimental molecule
  • Pregnant, or likely to be or breastfeeding, (Women of childbearing potential should have a pregnancy test (blood) negative 15 days before the date of the surgery) Using of a suitable method of contraception for patients of childbearing age during treatment. adequate contraception Methods includeare: an intrauterine device, hormonal contraception, condom use combined with a spermicide
  • Persons deprived of liberty or Trust (including curatorship)
  • Unable to undergo medical test for geographical, social or psychological.

Exclusion Criteria (intraoperative):

  • Persistent peritoneal lesions visible to the end of the surgery
  • Resection of the tail of the pancreas or pancreatic break (because no drainage post-op); break pleural (for K cardia)
  • Presence of metastasis in reach during surgery (except for ovarian metastasis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Schema B (140µg)
  • D0 : 20 μg of catumaxomab
  • D2 : 40 μg
  • D4 : 80 μg
Drug: Catumaxomab 140µg
Experimental: Schema A (100µg)
  • D0 : 10 μg of catumaxomab
  • D2 : 30 μg
  • D4 : 60 μg
Drug: Catumaxomab 100µg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival
Time Frame: every 3 months for the first two years
every 3 months for the first two years

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival
Time Frame: every 3 months for the first two years then every 4 months on year 3 then every 6 months on year 4 and 5
every 3 months for the first two years then every 4 months on year 3 then every 6 months on year 4 and 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

February 4, 2013

First Submitted That Met QC Criteria

February 5, 2013

First Posted (Estimate)

February 6, 2013

Study Record Updates

Last Update Posted (Estimate)

January 26, 2017

Last Update Submitted That Met QC Criteria

January 25, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-000475-17
  • 2011/1793 (Other Identifier: CSET number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Patients With Gastric Peritoneal Carcinomatosis

Clinical Trials on Catumaxomab 140µg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe