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

NCT ID: NCT01784900

Last Updated: 2017-01-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2016-01-31

Brief Summary

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

Conditions

Patients With Gastric Peritoneal Carcinomatosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Schema B (140µg)

• D0 : 20 μg of catumaxomab
• D2 : 40 μg
• D4 : 80 μg

Group Type: EXPERIMENTAL

Catumaxomab 140µg

Intervention Type: DRUG

Schema A (100µg)

• D0 : 10 μg of catumaxomab
• D2 : 30 μg
• D4 : 60 μg

Group Type: EXPERIMENTAL

Catumaxomab 100µg

Intervention Type: DRUG

Interventions

Catumaxomab 100µg

Intervention Type: DRUG

Catumaxomab 140µg

Intervention Type: DRUG

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

• 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.

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut Gustave Roussy

Villejuif, Val de Marne, France

Countries

France

Other Identifiers

2011/1793

Identifier Type: OTHER

Identifier Source: secondary_id

2012-000475-17

Identifier Type: -

Identifier Source: org_study_id