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

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ClinicalTrials.gov Identifier: NCT01784900
Recruitment Status : Terminated
First Posted : February 6, 2013
Last Update Posted : January 26, 2017
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

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

Condition or disease Intervention/treatment Phase
Patients With Gastric Peritoneal Carcinomatosis Drug: Catumaxomab 100µg Drug: Catumaxomab 140µg Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Gastric Peritoneal Carcinomatosis by Association of Complete Surgical Resection of the Lesions and Intraperitoneal Immunotherapy Using Catumaxomab. A Randomized Phase II Trial.
Study Start Date : November 2012
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

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



Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: every 3 months for the first two years ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01784900


Locations
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France
Institut Gustave Roussy
Villejuif, Val de Marne, France, 94805
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris

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Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT01784900     History of Changes
Other Study ID Numbers: 2012-000475-17
2011/1793 ( Other Identifier: CSET number )
First Posted: February 6, 2013    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Carcinoma
Peritoneal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Catumaxomab
Antibodies, Bispecific
Gastrointestinal Agents
Immunologic Factors
Physiological Effects of Drugs