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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by AIO-Studien-gGmbH
Sponsor:
Collaborator:
Neovii Biotech
Information provided by (Responsible Party):
AIO-Studien-gGmbH
ClinicalTrials.gov Identifier:
NCT01504256
First received: January 3, 2012
Last updated: April 8, 2014
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
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
Drug: catumaxomab, Fluorouracil, leucovorin, oxaliplatin, docetaxel
Drug: Fluorouracil, leucovorin, oxaliplatin, docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AIO-Studien-gGmbH:

Primary Outcome Measures:
  • Rate of macroscopic complete remissions of peritoneal carcinomatosis [ Time Frame: Assessment after 14 - 18 weeks after start of treatment ] [ Designated as safety issue: No ]
    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) [ Time Frame: Assessment after 14 - 18 weeks after start of treatment ] [ Designated as safety issue: No ]
    All tumor evaluation is performed according to RECIST

  • Overall survival (OS) [ Time Frame: Assessment over minimum 16 months up to 3 years ] [ Designated as safety issue: No ]
    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) [ Time Frame: Assessment over minimum 16 months up to 3 years ] [ Designated as safety issue: No ]
    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) [ Time Frame: Assessment over minimum 16 months up to 3 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: Assessment over minimum 16 months up to 3 years ] [ Designated as safety issue: Yes ]
  • Immunoreaction against tumor in tissue samples [ Time Frame: 14 - 18 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 14 - 18 weeks ] [ Designated as safety issue: No ]
    blood and tumor tissue from every patient assessed at 2time points. the first Laparoscopy (before randomization) and the second Laparoscopy (after chemotherapy)


Estimated Enrollment: 42
Study Start Date: October 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: catumaxomab

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 Name: 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 Name: FLOT

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01504256

Contacts
Contact: Katrin Krause, B.Sc. Katrin.Krause@aio-studien-ggmbh.de
Contact: Aysun Karatas, Dr. Aysun.Karatas@aio-studien-ggmbh.de

Locations
Germany
Prof. Dr. F. Lordick Recruiting
Braunschweig, Germany, 38114
Contact: F. Lordick, Prof. Dr.       studienmedkliik3@klinikum-braunschweig.de   
Principal Investigator: F. Lordick, Prof. Dr.         
Sponsors and Collaborators
AIO-Studien-gGmbH
Neovii Biotech
Investigators
Principal Investigator: Florian Lordick, Prof. Dr. Medizinische Klinik III; Städtisches Klinikum Braunschweig gGmbH
  More Information

Additional Information:
No publications provided

Responsible Party: AIO-Studien-gGmbH
ClinicalTrials.gov Identifier: NCT01504256     History of Changes
Other Study ID Numbers: AIO-STO-0110, 2010-024111-13
Study First Received: January 3, 2012
Last Updated: April 8, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by AIO-Studien-gGmbH:
Adenocarcinoma
Esophagogastric Junction
Peritoneal Carcinomatosis
Catumaxomab
AIO-STO-0110

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Antibodies, Bispecific
Docetaxel
Fluorouracil
Oxaliplatin
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 21, 2014