NCT01504256

Catumaxomab for Treatment of Peritoneal Carcinomatosis in Patients With Gastric Adenocarcinomas

Explorative Trial to Investigate Catumaxomab (Anti-EpCAM x Anti-CD3) for Treatment of Peritoneal Carcinomatosis in Patients With Gastric Adenocarcinomas Prior to Gastrectomy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: AIO-Studien-gGmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the efficacy of catumaxomab by determination of the rate of macroscopic complete remissions of peritoneal carcinomatosis after treatment with one cycle (four doses) of catumaxomab followed by six cycles of routine neoadjuvant chemotherapy.

Conditions

• Gastric Adenocarcinoma With Peritoneal Carcinomatosis
• Siewert Type II Adenocarcinoma of Esophagogastric Junction With Peritoneal Carcinomatosis
• Siewert Type III Adenocarcinoma of Esophagogastric Junction With Peritoneal Carcinomatosis

Interventions

Type	Name	Description
DRUG	catumaxomab, Fluorouracil, leucovorin, oxaliplatin, docetaxel	Catumaxomab: 4 intraperitoneal infusions of catumaxomab at an escalating dose of 10µg (d0), 20µg (d3), 50µg (d7), and 150µg (d10) and 7 days after the last catumaxomab infusion FLOT; 6 cycles q2w: Fluorouracil 2600 mg/m² as 24h infusion (d1) , leucovorin 200mg/m² (d1), oxaliplatin 85 mg{m² (d1), docetaxel 50 mg/m² (d1)
DRUG	Fluorouracil, leucovorin, oxaliplatin, docetaxel	FLOT; 6 cycles q2w: Fluorouracil 2600 mg/m² as 24h infusion (d1) leucovorin 200mg/m² (d1) oxaliplatin 85 mg{m² (d1) docetaxel 50 mg/m² (d1)

Timeline

• Start date: 2011-10-01
• Primary completion: 2017-03-01
• Completion: 2017-07-01
• First posted: 2012-01-05
• Last updated: 2018-01-23

Locations

1 site across 1 country: Germany