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

G

Gustave Roussy

Status and phase

Terminated
Phase 2

Conditions

Patients With Gastric Peritoneal Carcinomatosis

Treatments

Drug: Catumaxomab 140µg
Drug: Catumaxomab 100µg

Study type

Interventional

Funder types

Other

Identifiers

NCT01784900
2012-000475-17
2011/1793 (Other Identifier)

Details and patient eligibility

About

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

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

26 participants in 2 patient groups

Schema B (140µg)
Experimental group
Description:
D0 : 20 μg of catumaxomab D2 : 40 μg D4 : 80 μg
Treatment:
Drug: Catumaxomab 140µg
Schema A (100µg)
Experimental group
Description:
D0 : 10 μg of catumaxomab D2 : 30 μg D4 : 60 μg
Treatment:
Drug: Catumaxomab 100µg

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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