A Trial of Erbitux for Recurrent and Metastatic Mucinous Gastrointestinal Adenocarcinoma Involving the Peritoneal Surfaces

Lilly

Status and phase: Completed; Phase 2

Conditions: Mucinous Gastrointestinal Adenocarcinoma

Treatments: Drug: cetuximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00162110

CA225-063

Details and patient eligibility

About

This is a Phase II open-label trial evaluating the efficacy, and safety of Erbitux in patients with mucinous gastrointestinal adenocarcinoma involving the peritoneal surface.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able to take care of self. Out of bed less than 50% of the day
• Absolute neutrophil count >=1,500
• Platelet count >=100,000
• Total bilirubin count <=1.5 times the upper limit of normal

Exclusion criteria

• Prior epidermal growth factor receptor antibody
• Prior treatment with Erbitux
• Other cancers

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

1

Active Comparator group

Treatment:

Drug: cetuximab