Mucinous Gastrointestinal Adenocarcinoma
Conditions
Brief 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.
Interventions
DRUGcetuximab
mg, IV, 225 mg/m2, weekly, 4-52 weeks depending on response.
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the efficacy of Erbitux in the treatment of mucinous gastrointestinal adenocarcinoma involving the peritoneal surfaces based on clinical response rate. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United States
Outcome results
None listed