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Phase II Study With Catumaxomab in Patients With Gastric Cancer After Neoadjuvant CTx and Curative Resection

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ClinicalTrials.gov Identifier: NCT00464893
Recruitment Status : Completed
First Posted : April 24, 2007
Last Update Posted : December 4, 2013
Sponsor:
Information provided by (Responsible Party):
Neovii Biotech

Tracking Information
First Submitted Date  ICMJE April 23, 2007
First Posted Date  ICMJE April 24, 2007
Last Update Posted Date December 4, 2013
Study Start Date  ICMJE April 2007
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2007)
rate of all specific postoperative complications newly observed during a period of 30 days after surgery in those study patients who received at least the first 3 doses of catumaxomab [ Time Frame: 30 days after last catumaxomab administration ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 23, 2007)
rate of all specific postoperative complications newly observed during a period of 30 days after surgery in those study patients who received at least the first 3 doses of catumaxomab
Change History Complete list of historical versions of study NCT00464893 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2009)
  • frequency, relationship and seriousness of adverse events [ Time Frame: 30 days after last catumaxomab administration ]
  • surgical resection rate [ Time Frame: after surgery ]
  • chemotherapeutic response rate [ Time Frame: after neoadjuvant CTx ]
  • overall survival at 3, 6, 9, 12 and 24 month after EOT, defined as the time from study enrolment until death [ Time Frame: 2 years ]
  • disease-free survival at 3, 6, 9, 12 18 and 24 months after EOT, defined as the time from study enrolment to the point of diagnosis of recurrent disease or death, whichever occurred first [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2007)
  • frequency, relationship and seriousness of adverse events
  • Clinically relevant laboratory results
  • vital functions
  • surgical resection rate
  • chemotherapeutic response rate
  • tumor staging
  • overall survival at 3, 6, 9, 12 and 24 month after EOT, defined as the time from study enrolment until death
  • disease-free survival at 3, 6, 9, 12 18 and 24 months after EOT, defined as the time from study enrolment to the point of diagnosis of recurrent disease or death, whichever occurred first
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Study With Catumaxomab in Patients With Gastric Cancer After Neoadjuvant CTx and Curative Resection
Official Title  ICMJE Multicenter, Open-label Phase II Study to Evaluate the Safety and Efficacy of the Trifunctional Bispecific Antibody Catumaxomab (Anti-EpCAM x Anti-CD3) in Patients With Gastric Adenocarcinoma After Neoadjuvant Chemotherapy and Intended Curative Resection
Brief Summary Primary evaluation of the safety, tolerability and feasibility regarding specific postoperative complications of an adjuvant treatment with catumaxomab administered after curative tumor resection subsequent to a neoadjuvant chemotherapy.
Detailed Description

An open-label, multi-center phase II study in surgically resectable patients after neoadjuvant ECX-chemotherapy, with confirmed diagnosis of gastric adenocarcinoma and with a high risk of disseminated tumor cells due to serosal infiltration or positive lymph nodes after curative gastrectomy.

Treatment with catumaxomab will consist of an initial dose of 10 µg given intraoperatively as an intraperitoneal bolus and of four postoperative ascending doses (10-20-50-150 µg)which will be administered as an i.p.-infusion using an installed abdominal i.p.-port on the postoperative days 7, 10, 13 and 16.

Catumaxomab is a trifunctional antibody targeting EpCAM on tumor cells and CD3 on T cells. Trifunctional antibodies represent a new concept for targeted anticancer therapy. This new antibody class has the capability to redirect T cells and accessory cells (e.g. macrophages, dendritic cells [DCs] and natural killer [NK] cells) to the tumor site. According to preclinical data, trifunctional antibodies activate these different immune effector cells, which can trigger a complex anti-tumor immune response.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Gastric Cancer
  • Gastric Adenocarcinoma
Intervention  ICMJE
  • Drug: Catumaxomab
    10 µg intraoperative and 4 ascending doses (10, 20, 50 and 150 µg) on day 7, 10, 13 and 16
    Other Name: Removab
  • Drug: catumaxomab
    10 µg intraoperatively and 4 ascending doses: 10, 20, 50 and 150 µg
    Other Name: Removab
Study Arms  ICMJE Active Comparator: catumaxomab arm
Patients will get first the chemotherapeutic regimen (Epirubicin, Cisplatin and Capecitabine or 5-Fluorouracil) consisting of three 21-day cycles, starting on the weeks 1, 4 and 7. Four weeks after CTx the D2 surgery will take place. Treatment with catumaxomab will consist of an initial dose of 10µg given intraoperatively as in intraperitoneal bolus and of four postoperative ascending doses.
Interventions:
  • Drug: Catumaxomab
  • Drug: catumaxomab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2007)
70
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • signed and dated informed consent
  • male or female patient at an age of 18 years or older
  • patient has a primary diagnosis of a histologically confirmed gastric adenocarcinoma (including GE junction Siewert-Type 2 or 3)
  • TNM-staging at screening of T3/T4, N+/-, M0 or T2, N+, M0
  • indication and eligibility for a neoadjuvant chemotherapeutic regimen featuring three cycles of ECX with 21 days per cycle
  • intended curative gastrectomy
  • Karnofsky index > 70

Exclusion Criteria:

  • Exposure to prior cancer therapy or planned adjuvant chemo- or radiotherapy of the current gastric cancer
  • prior diagnosis of any malignancy not cured by surgery alone less than 5 years before study entry
  • previous use of non-humanized monoclonal mouse or rat antibodies
  • treatment with another investigational product during this study or during the last 30 days prior to study start
  • presence of distant metastases
  • presence of constant immunosuppressive therapy
  • history of pancreas resection (also partial) or thoracotomy
  • presence of any acute or chronic systemic infection
  • patient with a bowel obstruction within the last 30 days
  • known contraindications to any of the planned ECX chemotherapeutics
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Germany,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00464893
Other Study ID Numbers  ICMJE IP-CAT-GC-03
EudraCT-Nr.:2006-002727-16
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Neovii Biotech
Study Sponsor  ICMJE Neovii Biotech
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carsten Bokemeyer, Prof MD University Clinic of Hamburg-Eppendorf; 20246 Hamburg / Germany
PRS Account Neovii Biotech
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP