Cetuximab, Radiotherapy and Twice Weekly Gemcitabine to Treat Pancreatic Cancer
NCT ID: NCT00225784
Last Updated: 2014-07-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
37 participants
INTERVENTIONAL
2005-02-28
2012-09-30
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cetuximab, Gemcitabine, RT
weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy
Cetuximab/Gemcitabine
Once weekly Cetuximab, twice weekly Gemcitabine for six weeks
Radiotherapy
Daily radiotherapy for 28 days
Interventions
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Cetuximab/Gemcitabine
Once weekly Cetuximab, twice weekly Gemcitabine for six weeks
Radiotherapy
Daily radiotherapy for 28 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Dartmouth-Hitchcock Medical Center
OTHER
Responsible Party
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Principal Investigators
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J Marc Pipas, MD
Role: PRINCIPAL_INVESTIGATOR
Dartmouth-Hitchcock Medical Center
Other Identifiers
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DMS 0432
Identifier Type: -
Identifier Source: org_study_id
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