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

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

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

Criteria

Inclusion Criteria:

• signed and dated informed consent

• male or female patient at an age of 18 years or older

• patient has a primary diagnosis of a histologically confirmed gastric adenocarcinoma (including GE junction Siewert-Type 2 or 3)

• TNM-staging at screening of T3/T4, N+/-, M0 or T2, N+, M0

• indication and eligibility for a neoadjuvant chemotherapeutic regimen featuring three cycles of ECX with 21 days per cycle

• intended curative gastrectomy

• Karnofsky index > 70

Exclusion Criteria:

• Exposure to prior cancer therapy or planned adjuvant chemo- or radiotherapy of the current gastric cancer

• prior diagnosis of any malignancy not cured by surgery alone less than 5 years before study entry

• previous use of non-humanized monoclonal mouse or rat antibodies

• treatment with another investigational product during this study or during the last 30 days prior to study start

• presence of distant metastases

• presence of constant immunosuppressive therapy

• history of pancreas resection (also partial) or thoracotomy

• presence of any acute or chronic systemic infection

• patient with a bowel obstruction within the last 30 days

• known contraindications to any of the planned ECX chemotherapeutics