A Trial of Erbitux for Recurrent and Metastatic Mucinous Gastrointestinal Adenocarcinoma Involving the Peritoneal Surfaces
Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mucinous Gastrointestinal Adenocarcinoma
Intervention: cetuximab (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Bristol-Myers Squibb Official(s) and/or principal investigator(s): Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb
Summary
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.
Clinical Details
Official title: A Phase II Trial of Erbitux for Recurrent and Metastatic Mucinous Gastrointestinal Adenocarcinoma Involving the Peritoneal Surfaces
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Evaluate the efficacy of Erbitux in the treatment of mucinous gastrointestinal adenocarcinoma involving the peritoneal surfaces based on clinical response rate.
Secondary outcome: To evaulate surgically resected tumor specimens of the EGF receptor, mucins 1-6, and anglogenic indices such as vessel counts, VEGF expression, and Ki-67 expression. To evaluate the safety of Erbitux monotherapy in this patient population.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Local Institution, New York, New York, United States
Local Institution, Cincinnati, Ohio, United States
Additional Information
BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
Starting date: November 2004
Last updated: February 12, 2010
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