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

NCT00464893 | Completed Phase 2 DMC

• 2 other identifiers: IP-CAT-GC-03EudraCT-Nr.:2006-002727-16
• Study Type: interventional
• Target: 70
• Locations: 4 countries
• Sites: 4

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.

Conditions

Gastric Cancer; Gastric Adenocarcinoma

Keywords

gastric cancer; catumaxomab; neoadjuvant chemotherapy; phase II; interoperative; trifunctional antibody

Outcome Measures

Primary Outcomes (1)

• 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

  30 days after last catumaxomab administration

Secondary Outcomes (5)

• frequency, relationship and seriousness of adverse events

  30 days after last catumaxomab administration

• surgical resection rate

  after surgery

• chemotherapeutic response rate

  after neoadjuvant CTx

• overall survival at 3, 6, 9, 12 and 24 month after EOT, defined as the time from study enrolment until death

  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

  2 years

Study Arms (1)

catumaxomab arm

ACTIVE COMPARATOR

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.

Drug: Catumaxomab

Interventions

catumaxomab DRUG

10 µg intraoperative and 4 ascending doses (10, 20, 50 and 150 µg) on day 7, 10, 13 and 16

Also known as: Removab

catumaxomab arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neovii Biotech: lead

Study Sites (4)

Unknown Facility

Innsbruck, Austria

Location

Unknown Facility

Hamburg, Berlin, Heidelberg, Köln, Halle, Germany

Location

Unknown Facility

Terrassa, Spain

Location

Unknown Facility

Nottingham, United Kingdom

Location

Related Publications (5)

• Heiss MM, Strohlein MA, Jager M, Kimmig R, Burges A, Schoberth A, Jauch KW, Schildberg FW, Lindhofer H. Immunotherapy of malignant ascites with trifunctional antibodies. Int J Cancer. 2005 Nov 10;117(3):435-43. doi: 10.1002/ijc.21165.

  PMID: 15906359 BACKGROUND

• Ruf P, Lindhofer H. Induction of a long-lasting antitumor immunity by a trifunctional bispecific antibody. Blood. 2001 Oct 15;98(8):2526-34. doi: 10.1182/blood.v98.8.2526.

  PMID: 11588051 BACKGROUND

• Riesenberg R, Buchner A, Pohla H, Lindhofer H. Lysis of prostate carcinoma cells by trifunctional bispecific antibodies (alpha EpCAM x alpha CD3). J Histochem Cytochem. 2001 Jul;49(7):911-7. doi: 10.1177/002215540104900711.

  PMID: 11410615 BACKGROUND

• Zeidler R, Mysliwietz J, Csanady M, Walz A, Ziegler I, Schmitt B, Wollenberg B, Lindhofer H. The Fc-region of a new class of intact bispecific antibody mediates activation of accessory cells and NK cells and induces direct phagocytosis of tumour cells. Br J Cancer. 2000 Jul;83(2):261-6. doi: 10.1054/bjoc.2000.1237.

  PMID: 10901380 BACKGROUND

• Zeidler R, Reisbach G, Wollenberg B, Lang S, Chaubal S, Schmitt B, Lindhofer H. Simultaneous activation of T cells and accessory cells by a new class of intact bispecific antibody results in efficient tumor cell killing. J Immunol. 1999 Aug 1;163(3):1246-52.

  PMID: 10415020 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

catumaxomab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Carsten Bokemeyer, Prof MD

  University Clinic of Hamburg-Eppendorf; 20246 Hamburg / Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2007
• First Posted: April 24, 2007
• Study Start: April 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2013
• Last Updated: December 4, 2013

Record last verified: 2013-12

Locations

AU (1); DE (1); GB (1); ES (1)