Status:
COMPLETED
Cetuximab, Radiotherapy and Twice Weekly Gemcitabine to Treat Pancreatic Cancer
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is designed to establish the safety and efficacy of a combination of Erbitux (cetuximab)/Gemzar (gemcitabine)/radiation in patients with pancreatic cancer.
Detailed Description
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 af...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00225784
Start Date
February 1 2005
End Date
September 1 2012
Last Update
July 16 2014
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