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

Sponsor
Gustave Roussy, Cancer Campus, Grand Paris (Other)
Overall Status
Terminated
CT.gov ID
NCT01784900
Collaborator
(none)
26
Enrollment
1
Location
2
Arms
38
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Catumaxomab 100µg
  • Drug: Catumaxomab 140µg
 Phase 2

Study Design

Study Type:
Interventional
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 :
Nov 1, 2012
Actual Primary Completion Date :
Jan 1, 2016
Actual Study Completion Date :
Jan 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Progression Free Survival [every 3 months for the first two years]

Secondary Outcome Measures

  1. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut Gustave Roussy Villejuif Val de Marne France 94805

Sponsors and Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT01784900
Other Study ID Numbers:
  • 2012-000475-17
  • 2011/1793
First Posted:
Feb 6, 2013
Last Update Posted:
Jan 26, 2017
Last Verified:
Jan 1, 2017
Additional relevant MeSH terms:
Carcinoma
Peritoneal Neoplasms
Catumaxomab
Antibodies, Bispecific

Study Results

No Results Posted as of Jan 26, 2017