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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2007-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Mucinous Gastrointestinal Adenocarcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type ACTIVE_COMPARATOR

cetuximab

Intervention Type DRUG

mg, IV, 225 mg/m2, weekly, 4-52 weeks depending on response.

Interventions

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cetuximab

mg, IV, 225 mg/m2, weekly, 4-52 weeks depending on response.

Intervention Type DRUG

Other Intervention Names

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Erbitux

Eligibility Criteria

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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