Catumaxomab for Treatment of Peritoneal Carcinomatosis in Patients With Gastric Adenocarcinomas (CatuNeo)

January 19, 2018 updated by: AIO-Studien-gGmbH

Explorative Trial to Investigate Catumaxomab (Anti-EpCAM x Anti-CD3) for Treatment of Peritoneal Carcinomatosis in Patients With Gastric Adenocarcinomas Prior to Gastrectomy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Leipzig, Germany, 04103
        • Prof. Dr. F. Lordick

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed diagnosis of resectable gastric adenocarcinoma or adenocarcinoma of the esophagogastric junction (type II and type III according to Siewerts classification)
  • Macroscopic peritoneal carcinomatosis (stage P1-4 according to Gilly et al., appendix 1)
  • Patients potentially eligible for gastrectomy after primary systemic (and intraperitoneal) treatment
  • Signed and dated informed consent before the start of specific protocol procedures
  • Age > 18 years
  • ECOG Performance Status of 0 or 1
  • Life expectancy of at least 12 weeks

  • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening

    • Hemoglobin > 10.0 g/dl
    • Leukocyte count > 4.000/μl; absolute neutrophil count (ANC) > 2.000/μl
    • Platelet count > = 100.000/µl
    • Total bilirubin < 1,5 times the upper limit of normal
    • ALT and AST < 3 x upper limit of normal
    • Alkaline phosphatase < 5 x ULN
    • Serum creatinine < 1.5 x upper limit of normal and creatinine clearance > 60 ml/min
  • The patient is willing and able to comply with the protocol for the duration of the study, including hospital visits for treatment and scheduled follow-up visits and examinations

Exclusion Criteria:

  • Distant metastasis other than peritoneal seedings
  • Prior diagnosis of any malignancy not cured by surgery alone less than 5 years before study entry
  • Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = < 1 year before enrolment
  • History of HIV infection or chronic hepatitis B or C
  • Active, clinically serious infections (> grade 2 NCI-CTC version 3.0)
  • Pre-existing neuropathy > grade 1 (NCI CTCAE), except for loss of tendon reflex
  • Patients with seizure disorder requiring medication (such as steroids or antiepileptics)
  • History of organ allograft
  • Patients undergoing renal dialysis
  • Known hypersensitivity to any of the drugs given in the study; known hypersensitivity to murine (rat and/or mouse) proteins
  • Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study

  • Excluded therapies and medications, previous and concomitant:

    • Prior anti-cancer chemotherapy or immunotherapy.
    • Investigational drug therapy outside of this trial during or within 4 weeks of study entry
    • Major surgery within 4 weeks of starting the study, and patients must have recovered from effects of major surgery
  • Pregnant or breast-feeding patients, or planning to become pregnant within 6 months after the end of treatment. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and for 6 months after the end of treatment
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's understanding of the informed consent procedure, participation in the study or evaluation of the study results

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: catumaxomab

this arm was stopped. the antibody previously used as a study drug is not available at this time. patients will be randomized only into the standard arm

[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: 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)

Other Names:
  • Catumaxomab + FLOT
ACTIVE_COMPARATOR: standard therapy

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)

Other Names:
  • FLOT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of macroscopic complete remissions of peritoneal carcinomatosis
Time Frame: Assessment after 14 - 18 weeks after start of treatment
Macroscopic complete response (mCR) rate of the peritoneal lesions, as resulting from the second diagnostic laparoscopy or laparotomy performed after chemotherapy.
Assessment after 14 - 18 weeks after start of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical resection rate (R0, R1, R2)
Time Frame: Assessment after 14 - 18 weeks after start of treatment
All tumor evaluation is performed according to RECIST
Assessment after 14 - 18 weeks after start of treatment
Overall survival (OS)
Time Frame: Assessment over minimum 16 months up to 3 years
The duration of overall survival (OS) will be determined by measuring the time interval from randomization to the date of death or last observation (censored).
Assessment over minimum 16 months up to 3 years
Disease-free survival (DFS)
Time Frame: Assessment over minimum 16 months up to 3 years
Disease-free survival (DFS) will be defined as the time from surgery, resulting in a R0 finding and macroscopic complete remission of PC, to the time of disease progression or relapse (according to RECIST) or death, or to the date of last assessment without any such event (censored observation). Patients with evidence of disease at surgery are counted as having the event at time = 0.
Assessment over minimum 16 months up to 3 years
Progression-free survival (PFS)
Time Frame: Assessment over minimum 16 months up to 3 years
Progression-free survival (PFS) will be defined as the time from randomization to the time of disease progression or relapse (according to RECIST) or death, or to the date of last assessment without any such event (censored observation).
Assessment over minimum 16 months up to 3 years
Frequency, relationship, and severity of AEs
Time Frame: Assessment over minimum 16 months up to 3 years
Assessment over minimum 16 months up to 3 years
Immunoreaction against tumor in tissue samples
Time Frame: 14 - 18 weeks
blood and tumor tissue from every patient assed at 2time points. the first Laparoscopy (before randomization)and the second Laparoscopy (after chemotherapy)
14 - 18 weeks
Detection of disseminated tumor cells via PCR
Time Frame: 14 - 18 weeks
blood and tumor tissue from every patient assessed at 2time points. the first Laparoscopy (before randomization) and the second Laparoscopy (after chemotherapy)
14 - 18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AIO-Studien-gGmbH

Collaborators

Neovii Biotech

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ACTUAL)

March 1, 2017

Study Completion (ACTUAL)

July 1, 2017

Study Registration Dates

First Submitted

January 3, 2012

First Submitted That Met QC Criteria

January 4, 2012

First Posted (ESTIMATE)

January 5, 2012

Study Record Updates

Last Update Posted (ACTUAL)

January 23, 2018

Last Update Submitted That Met QC Criteria

January 19, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIO-STO-0110
  • 2010-024111-13 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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