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TerminatedNCT01784900IIPOPUpdated Jan 26, 2017

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

A Phase 2 interventional study of Catumaxomab 100µg and Catumaxomab 140µg in Patients With Gastric Peritoneal Carcinomatosis, sponsored by Gustave Roussy, Cancer Campus, Grand Paris. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-26.

Sponsored by Gustave Roussy, Cancer Campus, Grand Paris · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Patients With Gastric Peritoneal Carcinomatosis
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 26 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris is the lead sponsor of 242 studies on the registry; 65 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • 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

Interventions

  • DrugCatumaxomab 100µg
  • DrugCatumaxomab 140µg
06

What researchers measure

Primary outcomes

  1. Progression Free Survival

    Time frame: every 3 months for the first two years

Secondary outcomes

  1. 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

07

Study locations

1 site
  • Institut Gustave Roussy
    Villejuif, Val de Marne 94805, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01784900
Lead sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Responsible party
Sponsor
First posted
Feb 6, 2013
Start date
Nov 2012
Primary completion
Jan 2016
Completion
Jan 2016
Last update
Jan 26, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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