Status:
COMPLETED
PhI Study of Erbitux & Gemcitabine w/Radiation Therapy for Locally Adv. Pancreas Ca
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodi...
Detailed Description
OBJECTIVES: * Determine the maximum tolerated dose of gemcitabine hydrochloride when administered with cetuximab and radiotherapy in patients with unresectable locally advanced pancreatic or periampu...
Eligibility Criteria
Inclusion
- Histologically confirmed adenocarcinoma of the pancreas (head, body, or tail) or periampullary region, meeting both of the following criteria:
- Unresectable disease
- Locally advanced disease
- Measurable or evaluable disease by CT scan or MRI
- No evidence of metastatic disease outside of the planned irradiation field
- ECOG performance status 0-2
- WBC ≥ 3,000/mm³
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 8.5 g/dL
- AST and ALT ≤ 5 times upper limit of normal
- Bilirubin ≤ 2.0 mg/dL
- Creatinine ≤ 2.0 mg/dL
- No clinical indication of compromised function of nonirradiated kidney
- No secondary malignancies within the past 5 years except for resected nonmelanoma skin cancer or carcinoma in situ of the cervix
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
Exclusion
- No acute hepatitis
- No known HIV infection
- No other active or uncontrolled infection
- No significant history of uncontrolled cardiac disease, including any of the following:
- Hypertension
- Unstable angina
- Myocardial infarction within the past 6 months
- Congestive heart failure
- Cardiomyopathy with decreased ejection fraction
- No prior severe infusion reaction to a monoclonal antibody
- PRIOR CONCURRENT THERAPY:
- No prior radiotherapy to planned field of treatment
- No prior therapy that specifically and directly targets EGFR pathway
- At least 14 days since prior surgery or biopsy
- At least 28 days since prior bypass procedures
- More than 5 years since prior and no other concurrent chemotherapy
- No other concurrent investigational agent
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00467116
Start Date
October 1 2005
End Date
October 1 2007
Last Update
May 18 2012
Active Locations (1)
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1
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838