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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
catumaxomab, Fluorouracil, leucovorin, oxaliplatin, docetaxel
Fluorouracil, leucovorin, oxaliplatin, docetaxel
Sponsored by
AIO-Studien-gGmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Adenocarcinoma With Peritoneal Carcinomatosis focused on measuring Adenocarcinoma, Esophagogastric Junction, Peritoneal Carcinomatosis, Catumaxomab, AIO-STO-0110

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Prof. Dr. F. Lordick

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

catumaxomab

standard therapy

Arm Description

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))

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)

Outcomes

Primary Outcome Measures

Rate of macroscopic complete remissions of peritoneal carcinomatosis
Macroscopic complete response (mCR) rate of the peritoneal lesions, as resulting from the second diagnostic laparoscopy or laparotomy performed after chemotherapy.

Secondary Outcome Measures

Surgical resection rate (R0, R1, R2)
All tumor evaluation is performed according to RECIST
Overall survival (OS)
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).
Disease-free survival (DFS)
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.
Progression-free survival (PFS)
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).
Frequency, relationship, and severity of AEs
Immunoreaction against tumor in tissue samples
blood and tumor tissue from every patient assed at 2time points. the first Laparoscopy (before randomization)and the second Laparoscopy (after chemotherapy)
Detection of disseminated tumor cells via PCR
blood and tumor tissue from every patient assessed at 2time points. the first Laparoscopy (before randomization) and the second Laparoscopy (after chemotherapy)

Full Information

First Posted
January 3, 2012
Last Updated
January 19, 2018
Sponsor
AIO-Studien-gGmbH
Collaborators
Neovii Biotech
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1. Study Identification

Unique Protocol Identification Number
NCT01504256
Brief Title
Catumaxomab for Treatment of Peritoneal Carcinomatosis in Patients With Gastric Adenocarcinomas
Acronym
CatuNeo
Official Title
Explorative Trial to Investigate Catumaxomab (Anti-EpCAM x Anti-CD3) for Treatment of Peritoneal Carcinomatosis in Patients With Gastric Adenocarcinomas Prior to Gastrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AIO-Studien-gGmbH
Collaborators
Neovii Biotech

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Adenocarcinoma, Esophagogastric Junction, Peritoneal Carcinomatosis, Catumaxomab, AIO-STO-0110

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
catumaxomab
Arm Type
Experimental
Arm Description
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))
Arm Title
standard therapy
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
catumaxomab, Fluorouracil, leucovorin, oxaliplatin, docetaxel
Other Intervention Name(s)
Catumaxomab + FLOT
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Fluorouracil, leucovorin, oxaliplatin, docetaxel
Other Intervention Name(s)
FLOT
Intervention Description
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)
Primary Outcome Measure Information:
Title
Rate of macroscopic complete remissions of peritoneal carcinomatosis
Description
Macroscopic complete response (mCR) rate of the peritoneal lesions, as resulting from the second diagnostic laparoscopy or laparotomy performed after chemotherapy.
Time Frame
Assessment after 14 - 18 weeks after start of treatment
Secondary Outcome Measure Information:
Title
Surgical resection rate (R0, R1, R2)
Description
All tumor evaluation is performed according to RECIST
Time Frame
Assessment after 14 - 18 weeks after start of treatment
Title
Overall survival (OS)
Description
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).
Time Frame
Assessment over minimum 16 months up to 3 years
Title
Disease-free survival (DFS)
Description
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.
Time Frame
Assessment over minimum 16 months up to 3 years
Title
Progression-free survival (PFS)
Description
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).
Time Frame
Assessment over minimum 16 months up to 3 years
Title
Frequency, relationship, and severity of AEs
Time Frame
Assessment over minimum 16 months up to 3 years
Title
Immunoreaction against tumor in tissue samples
Description
blood and tumor tissue from every patient assed at 2time points. the first Laparoscopy (before randomization)and the second Laparoscopy (after chemotherapy)
Time Frame
14 - 18 weeks
Title
Detection of disseminated tumor cells via PCR
Description
blood and tumor tissue from every patient assessed at 2time points. the first Laparoscopy (before randomization) and the second Laparoscopy (after chemotherapy)
Time Frame
14 - 18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florian Lordick, Prof. Dr.
Organizational Affiliation
Universitäres Krebszentrum Leipzig (UCCL), Universität Leipzig, Medizinische Fakultät
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prof. Dr. F. Lordick
City
Leipzig
ZIP/Postal Code
04103
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.aio-portal.de
Description
AIO - Working Group for Medical Oncology from the German Cancer Society

Learn more about this trial

Catumaxomab for Treatment of Peritoneal Carcinomatosis in Patients With Gastric Adenocarcinomas

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