Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Adenocarcinoma

Stomach Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gastrointestinal Agents

Fluorouracil

Antibodies

Capecitabine

Cisplatin

Epirubicin

Antibodies, Bispecific

Immunoglobulins

Muromonab-CD3

Catumaxomab

Immunologic Factors

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.

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

10 µg intraoperatively and 4 ascending doses: 10, 20, 50 and 150 µg

catumaxomab

Carsten Bokemeyer, Prof MD

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.

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.

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

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

Neovii Biotech

Symptoms and General Pathology

Ascites

Anti-Inflammatory Agents

Antiemetics

Neuroprotective Agents

Antibodies, Monoclonal

Prednisolone

Immunomodulating Agents

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Patients will receive premedication of 25 mg (i.v.) prednisolone 30 minutes prior start of infusion of catumaxomab.

Catumaxomab will be infused i.p. with 3 hour constant rate infusions via an indwelling catheter.

Catumaxomab will be administered in a dosage identical to Arm A but without the prednisolone premedication.

Catumaxomab will be infused 4 times within 11 days as follows:

10 µg on day 0, 20 µg on day 3, 50 µg on day 7, 150 µg on day 10

Florian Lordick, PD Dr. med.

This is a randomized phase IIIb study investigating the treatment of malignant ascites due to epithelial cancer (carcinomas) with the trifunctional antibody catumaxomab. In order to make the catumaxomab treatment more convenient for the patient and the hospital praxis the tolerability of 3 hour infusions of catumaxomab with and without premedication of prednisolone is evaluated.

A total of 208 patients with malignant ascites due to epithelial cancer will be allocated to two treatment groups in a 1:1 ratio.

Safety data of the completed pivotal phase II/III trial, IP-REM-AC-01, in which catumaxomab was administered as 6 hour i.p. infusion showed that most reported AEs were cytokine release-related symptoms such as fever, nausea, and vomiting (based on the pharmacodynamic mode of action of catumaxomab) and abdominal pain. In order to make the catumaxomab treatment more convenient for the patient and the hospital praxis the current trial was designed to determine whether tolerability of the 3 hour infusion of catumaxomab with and without premedication of prednisolone. Prednisolone was chosen as additional premedication with the objective to reduce cytokine release related symptoms which might change with the switch from 6 to 3 h infusion time.

CASIMAS: Catumaxomab Safety Phase IIIb Study With Intraperitoneal Infusion in Patients With Malignant Ascites Due to Epithelial Cancers

Two-arm, Randomized, Open-label, Phase IIIb Study Investigating the Safety of a 3 Hour i.p. Infusion of Catumaxomab With and Without Prednisolone Premedication in Patients With Malignant Ascites Due to Epithelial Cancer

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Ovarian Cancer

Ovarian Epithelial Cancer

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

Jahlid Sehouli, MD

Primary evaluation of the safety, tolerability and feasibility regarding specific postoperative complications of an adjuvant treatment with catumaxomab administered after tumor resection.

An open label, multi-center, single-arm, phase II study according to Fleming´s one-stage design. The surgical procedure on Day 0 will be performed according to AGO State of the Art, followed by one intraoperative and four postoperative intraperitoneal administrations of catumaxomab within 16 days. The Discharge Visit will be performed when the patient is leaving the hospital but not earlier than 1 day after the last infustion, followed by the End of Study Visit on Day 30.

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.

Phase II Study of the Trifunctional Antibody Catumaxomab Administered Intra- and Postoperatively in Patients With Ovarian Cancer

Multicenter, Single-arm, Phase II Study of the Trifunctional Antibody Catumaxomab (Anti-EpCAM x Anti-CD3) Administered Intra- and Postoperatively in Patients With Epithelial Ovarian Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase II Study With Catumaxomab in Patients With Gastric Cancer After Neoadjuvant CTx and Curative Resection	NCT00464893	Gastric Cancer Gastric Adenoca...	Catumaxomab catumaxomab	18 Years -	Neovii Biotech
CASIMAS: Catumaxomab Safety Phase IIIb Study With Intraperitoneal Infusion in Patients With Malignant Ascites Due to Epithelial Cancers	NCT00822809	Cancer Neoplasms Carcinoma Malignant Ascit...	Catumaxomab Prednisolone	18 Years -	Neovii Biotech
Phase II Study of the Trifunctional Antibody Catumaxomab Administered Intra- and Postoperatively in Patients With Ovarian Cancer	NCT00563836	Ovarian Cancer Epithelial Ovar...	Catumaxomab	18 Years -	Neovii Biotech
Phase II Study of the Trifunctional Antibody Catumaxomab Administered Intra- and Postoperatively in Patients With Ovarian Cancer	NCT00563836	Ovarian Cancer Epithelial Ovar...	Catumaxomab	18 Years -	Neovii Biotech

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