A Phase II Trial of Cetuximab, Radiotherapy and Twice Weekly Gemcitabine in Patients With Adenocarcinoma of the Pancreas
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
A Phase II Trial of Cetuximab, Radiotherapy and Twice Weekly Gemcitabine in Patients With Adenocarcinoma of the Pancreas
The study treatment for this protocol is
- Loading dose of Cetuximab 400 mg/m2
- Weekly Cetuximab 250 mg/m2
- Bi-weekly Gemcitabine 50 mg/m2
- Daily Radiation for 28 fractions
- CT scan four weeks after completion of treatment
- Evaluation by surgeon for resectability
Inclusion Criteria:
- Histologic proof of pancreatic adenocarcinoma
- Clinical stage I, II, or III disease
- Radiographically measurable disease
- Tumor tissue for epidermal growth factor receptor (EGFR) status by
immunohistochemistry
- Signed protocol consent
- Karnofsky performance status of at least 70%
- Age > or = to 18 years
- Patients must either not be of child bearing potential or have a negative pregnancy
test within 72 hours of treatment.
- Absolute neutrophil count (ANC) > 1500; platelets > 100,000/ul.
- Creatinine < 1.5 x upper limit of normal (ULN)
- Bilirubin < 1.5 x ULN; AST < 2.5 x ULN.
Exclusion Criteria:
- Acute hepatitis or known HIV
- Active or uncontrolled infection
- Significant history of cardiac disease
- Prior therapy which affects or targets the EGF pathway
- Prior severe infusion reaction to a monoclonal antibody
- Any concurrent chemotherapy not indicated in the study protocol or any other
investigational agents
- Any previous chemotherapy or abdominal or pelvic radiotherapy
- No prior malignancy is allowed except for adequately treated basal cell or squamous
cell skin cancer, in situ cervical cancer, or malignancy for which the patient has
been disease free for five years.
- Any severe pre-existing medical or psychiatric condition, which, in the opinion of
the attending physician, will interfere with safe and appropriate treatment and
follow-up on study
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Objective Response of Tumor by RECIST 1.0 Criteria
Outcome Description:
Per RECIST Criteria (v. 1.0) and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in sum of the longest diameter (SLD)of target lesions at baseline; Progressive Disease (PD), >=20% increase in the SLD of target lesions at baseline; Stable Disease (SD), Neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD.
Outcome Time Frame:
one month post-therapy
Safety Issue:
No
Principal Investigator
J Marc Pipas, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dartmouth-Hitchcock Medical Center
Authority:
United States: Food and Drug Administration
Study ID:
DMS 0432
NCT ID:
NCT00225784
Start Date:
February 2005
Completion Date:
December 2017
Related Keywords:
- Pancreatic Cancer
- Stage I, II, III pancreatic adenocarcinoma
- Radiographically measurable disease
- Adenocarcinoma
- Pancreatic Neoplasms
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