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

Patients With Gastric Peritoneal Carcinomatosis Clinical Trial

— IIPOP  

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01784900
• Other study ID #: 2012-000475-17
• Secondary ID: 2011/1793
• Status: Terminated
• Phase: Phase 2
• First received: February 4, 2013
• Last updated: January 25, 2017
• Start date: November 2012
• Est. completion date: January 2016

Study information

• Verified date: January 2017
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Patients With Gastric Peritoneal Carcinomatosis

Intervention

Drug:
• Catumaxomab 100µg

• Catumaxomab 140µg

Locations

Country	Name	City	State
France	Institut Gustave Roussy	Villejuif	Val de Marne

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival		every 3 months for the first two years
Secondary	Progression Free Survival		every 3 months for the first two years then every 4 months on year 3 then every 6 months on year 4 and 5