A study to investigate the safety, tolerability and feasibility regarding specific postoperative complications after intraoperative treatment with catumaxomab subsequent to a neoadjuvant chemotherapy and curative tumor resection

• Conditions: Gastric Neoplasm malignant; MedDRA version: 15.0Level: HLTClassification code 10017812Term: Gastric neoplasms malignantSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2006-002727-16-DE
• Lead Sponsor: Fresenius Biotech GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-01
• Last Update Posted: 14 October 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Signed and dated informed consent
2. Male or female patient at an age of 18 years or older
3. Patient has a primary diagnosis of a histologically confirmed gastric adenocarcinoma (including GE junction Siewert-Type 2 or 3)
4. TNM-staging at screening of T2/T3/T4, N+/-, M0
5. Intended curative subtotal or total gastrectomy ('en-bloc'-R0-resection considering the standard D2-scheme)
6. Karnofsky index >= 70
7. Negative pregnancy blood test at screening but not more than 72 hours prior to the start of chemotherapy, for women of childbearing potential

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

1. Exposure to prior cancer therapy (surgery, chemo- or radio-therapy) or planned adjuvant chemo- or radiotherapy of the current gastric cancer before End-of-Treatment visit (EOT = 1 month after last catumaxomab administration)
2. Prior diagnosis of any malignancy not cured by surgery alone less than 5 years before study entry (except cervix carcinoma in situ and adequately treated non-melanomatous skin cancer)
3. Previous use of non-humanized monoclonal mouse or rat antibodies
4. Known or suspected hypersensitivity or allergy to catumaxomab or to similar antibodies or to any of the planned ECX chemotherapeutic drugs
5. Known dihydropyrimidine-dehydrogenase (DPDH) deficiency
6. Known contraindications to any of the planned ECX-chemotherapeutics
7. Presence of distant metastases
8. Presence of constant immunosuppressive therapy
9. Presence of bilateral pleural effusion or hypalbuminemia associated with hypovolemia and hypotension
10. Presence of symptomatic pyloric stenosis (defined as excessive vomiting and weight loss > 10% within the last 3 months)
11. Presence of any acute or chronic systemic infection
12. Presence of a bowel obstruction within the last 30 days
13. Pre-existing heart failure > NYHA class II
14. Inadequate renal function (Creatinine >1.5 x ULN or Creatinine Clearance < 60 ml/min/kg according to the Cockroft Formula)
15. Inadequate hepatic function (AST or ALT > 2.5 x ULN or Bilirubin > 1.5 x ULN)
16. Inadequate bone marrow function with Platelets < 100 000 cells/mm3 or absolute neutrophil count (ANC) < 1500 cells/mm3
17. Left ventricular ejection fraction (LVEF) below normal institutional ranges as measured by echocardiogram or any clinically significant abnormality detected by echocardiogram
18. Pregnant or nursing woman, or woman of childbearing potential who is not using an adequate and effective contraceptive method during the study and at least three months after the last i.p.-infusion (i.e., oral or injectable contraceptives, intrauterine devices, double-barrier method, contraceptive patch, male partner sterilization or condoms)
19. Any further condition which according to the investigator results in an undue risk to the patient during participation in the present study
20. The patient planned to be enrolled is an employee of any involved study investigator or of any involved institution including the study sponsor
21. Parallel participation in another clinical trial or previously in this study
22. Treatment with another investigational product during this study or during the last 30 days prior to study start

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified