Safety and Efficacy Study With Catumaxomab in Patients After Curative Resection of a Gastric Adenocarcinoma - Full Text View

Sponsored by:	Fresenius Biotech GmbH
Information provided by:	Fresenius Biotech GmbH
ClinicalTrials.gov Identifier:	NCT00352833

Purpose

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.

Condition	Intervention	Phase
Gastric Cancer Gastric Adenocarcinoma	Drug: catumaxomab	Phase II

MedlinePlus related topics: Cancer Stomach Cancer Surgery

Drug Information available for: Catumaxomab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Multicenter, Open-Label and Randomized Phase II Study to Evaluate Safety and Efficacy of the Trifunctional Bispecific Antibody Catumaxomab (Anti-EpCAM x Anti-CD3) in Patients After Curative Resection of a Confirmed Gastric Adenocarcinoma Compared With Surgery Alone

Further study details as provided by Fresenius Biotech GmbH:

Primary Outcome Measures:

safety and efficacy data

Estimated Enrollment:	40
Study Start Date:	July 2006
Study Completion Date:	September 2007

Detailed Description:

A controlled, randomized, open-label, multi-center, parallel-group, Phase II study to generate valid hypotheses on safety and efficacy issues in patients with a primary confirmed diagnosis of gastric adenocarcinoma and a high risk of disseminated tumor cells due to serosal infiltration after curative gastrectomy. Eligible patients will be centrally randomized by IVRS during operation to one of the two study groups in an 1:1 ratio: surgery plus catumaxomab or surgery alone. Treatment with catumaxomab will consist of an initial dose of 10 µg given intraoperatively as an intraperitoneal bolus on day 0 and of four following ascending doses (10-20-50-150 µg) which will be administered as an i.p.-infusion via a provided indwelling catheter on the days 7, 10, 13 and 16, respectively.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
Patient is an employee of any involved study investigator or any involved institution including the study sponsor
Parallel participation in another clinical trial or previous participation in this study
Treatment with another investigational product during this study or during the last 30 days prior to study start

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00352833

Locations

Germany
Hospital of Cologne-Merheim, Surgical Department
Cologne, Germany, 51109

Sponsors and Collaborators

Fresenius Biotech GmbH

Investigators

Principal Investigator:

Marcus Heiss, Prof. Dr.

Cologne, Germany

More Information

Publications:

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.

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

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.

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.

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.

Study ID Numbers:	IP-REM-GC-02
Study First Received:	July 14, 2006
Last Updated:	October 25, 2007
ClinicalTrials.gov Identifier:	NCT00352833 History of Changes
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by Fresenius Biotech GmbH:

gastric cancer
investigational drug
adjuvant therapy

intraoperative
intraperitoneal
EpCAM-positive tumor

Study placed in the following topic categories:

Digestive System Neoplasms
Gastrointestinal Diseases
Adjuvants, Immunologic
Antibodies, Bispecific
Carcinoma
Antibodies
Digestive System Diseases

Stomach Diseases
Stomach Neoplasms
Gastrointestinal Neoplasms
Stomach Cancer
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Immunoglobulins

Additional relevant MeSH terms:

Neoplasms
Stomach Diseases
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Neoplasms by Histologic Type

Gastrointestinal Diseases
Stomach Neoplasms
Gastrointestinal Neoplasms
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on May 07, 2009