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


Phase 2
18 Years
N/A
Not Enrolling
Both
Mucinous Gastrointestinal Adenocarcinoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate the efficacy of Erbitux in the treatment of mucinous gastrointestinal adenocarcinoma involving the peritoneal surfaces based on clinical response rate.

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA225-063

NCT ID:

NCT00162110

Start Date:

November 2004

Completion Date:

January 2007

Related Keywords:

  • Mucinous Gastrointestinal Adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous

Name

Location

Local InstitutionBronx, New York  
Local InstitutionCincinnati, Ohio