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

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neovii Biotech
• Treatments: Antibodies, Bispecific; Catumaxomab

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