Safety and Efficacy Study With Catumaxomab in Patients After Curative Resection of a Gastric Adenocarcinoma

NCT00352833 | Completed Phase 2

• 1 other identifier: IP-REM-GC-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Investigation of the outcome of an adjuvant treatment with catumaxomab as compared to surgery alone in patients after curative resection of a gastric adenocarcinoma in order to gain more detailed information primary on safety, tolerability and feasibility and secondary on relevant efficacy parameters.

Conditions

Gastric Cancer; Gastric Adenocarcinoma

Keywords

gastric cancer; investigational drug; adjuvant therapy; intraoperative; intraperitoneal; EpCAM-positive tumor

Outcome Measures

Primary Outcomes (1)

• safety and efficacy data

Interventions

catumaxomab DRUG

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
• Patient has a primary diagnosis of a histologically confirmed gastric adenocarcinoma (including GE junction Siewert-Type 2 or 3)
• Intended curative gastrectomy ('en-bloc´-R0-resection considering the standard D2-scheme)
• Serosal infiltration (T3/T4, N+/-, M0) confirmed by immediate section with histopathologic assessment during surgery
• Karnofsky index \>= 70
• Negative pregnancy blood test at screening in women with childbearing potential

You may not qualify if:

• Presence of distant metastases
• Macroscopic and microscopic residual tumor present after surgery
• State after pancreas resection or thoracotomy
• Exposure to prior cancer therapy or planned adjuvant chemo-or radiotherapy of the current gastric cancer
• Previous treatment with non-humanized mouse or rat monoclonal antibodies
• Known/suspected hypersensitivity to catumaxomab or similar antibodies
• Any cancer disease or any cancer treatments within the last 5 years
• Presence of constant immunosuppressive therapy
• Inadequate renal function (creatinine \> 1.5 x ULN)
• Inadequate hepatic function (AST or ALT \> 2.5 x ULN or bilirubin \>= 1.5 x ULN)
• Platelets \< 75000 cells/mm³; absolute neutrophil count \< 1500 cells/mm³
• Patient had a bowel obstruction within the last 30 days
• Pregnant or nursing woman, or woman of childbearing potential who is not using an effective contraceptive method during the study and at least contraceptives, intrauterine devices, double-barrier method, contraceptive patch, male partner sterilization or condoms)
• Presence of any acute or chronic systemic infection
• Any further condition which according to the investigator results in an undue risk to the patient during participating in the present study

Sponsors & Collaborators

• Neovii Biotech: lead

Study Sites (1)

Hospital of Cologne-Merheim, Surgical Department

Cologne, 51109, Germany

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

• Marcus Heiss, Prof. Dr.

  Cologne, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 14, 2006
• First Posted: July 17, 2006
• Study Start: July 1, 2006
• Study Completion: September 1, 2007
• Last Updated: October 26, 2007

Record last verified: 2007-06

Locations

DE (1)