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Catumaxomab for Treatment of Peritoneal Carcinomatosis in Patients With Gastric Adenocarcinomas

NCT01504256 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2018-01-23

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy of catumaxomab by determination of the rate of macroscopic complete remissions of peritoneal carcinomatosis after treatment with one cycle (four doses) of catumaxomab followed by six cycles of routine neoadjuvant chemotherapy.

Conditions

  • Gastric Adenocarcinoma With Peritoneal Carcinomatosis
  • Siewert Type II Adenocarcinoma of Esophagogastric Junction With Peritoneal Carcinomatosis
  • Siewert Type III Adenocarcinoma of Esophagogastric Junction With Peritoneal Carcinomatosis

Interventions

DRUG

catumaxomab, Fluorouracil, leucovorin, oxaliplatin, docetaxel

Catumaxomab: 4 intraperitoneal infusions of catumaxomab at an escalating dose of 10µg (d0), 20µg (d3), 50µg (d7), and 150µg (d10) and 7 days after the last catumaxomab infusion FLOT; 6 cycles q2w: Fluorouracil 2600 mg/m² as 24h infusion (d1) , leucovorin 200mg/m² (d1), oxaliplatin 85 mg{m² (d1), docetaxel 50 mg/m² (d1)

DRUG

Fluorouracil, leucovorin, oxaliplatin, docetaxel

FLOT; 6 cycles q2w: Fluorouracil 2600 mg/m² as 24h infusion (d1) leucovorin 200mg/m² (d1) oxaliplatin 85 mg{m² (d1) docetaxel 50 mg/m² (d1)

Sponsors & Collaborators

  • Neovii Biotech

    collaborator INDUSTRY

  • AIO-Studien-gGmbH

    lead OTHER

Principal Investigators

  • Florian Lordick, Prof. Dr. · Universitäres Krebszentrum Leipzig (UCCL), Universität Leipzig, Medizinische Fakultät

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2017-03-31
Completion
2017-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01504256 on ClinicalTrials.gov