Status:
COMPLETED
Cetuximab, Gemcitabine, and Oxaliplatin Followed By Surgery or External-Beam Radiation Therapy and Capecitabine in Treating Patients With Locally Advanced, Nonmetastatic Pancreatic Cancer That Cannot Be Removed By Surgery
Lead Sponsor:
Medical University of South Carolina
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or c...
Detailed Description
OBJECTIVES: Primary * Determine the progression-free survival rate in patients with unresectable, locally advanced, nonmetastatic adenocarcinoma of the pancreas treated with neoadjuvant therapy comp...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or radiologically confirmed pancreatic cancer, meeting both of the following criteria:
- Locally advanced, nonmetastatic disease
- Surgically unresectable disease
- Measurable disease, defined as unidimensionally measurable by physical exam or imaging study
- The following are considered nonmeasurable disease:
- Bone-only disease
- Pleural or peritoneal effusions
- CNS lesions
- Irradiated lesions in the absence of progression after radiotherapy
- No history or evidence of CNS disease
- No metastatic disease to distant organs (e.g., liver, lung, brain, or bone)
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Granulocyte count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Bilirubin ≤ 2.0 mg/dL
- Creatinine ≤ 2.0 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for ≥ 90 days after completion of study therapy
- No acute hepatitis
- No known HIV positivity
- No active or uncontrolled infection
- No significant history of uncontrolled cardiac disease, including, but not limited to, any of the following:
- Uncontrolled hypertension
- Unstable angina
- Myocardial infarction within the past 6 months
- Uncontrolled congestive heart failure
- Cardiomyopathy with decreased ejection fraction
- No prior severe infusion reaction to a monoclonal antibody
- No active second malignancy other than nonmelanoma skin cancer
- No history of deep vein thrombosis
- No history of bleeding diathesis or coagulopathy
- No other severe concurrent disease, mental incapacitation, or psychiatric illness that would preclude study participation
- PRIOR CONCURRENT THERAPY:
- No prior therapy for pancreatic cancer
- No prior therapy specifically targeting the epidermal growth factor-receptor pathway
- No major surgical procedure or open biopsy within the past 28 days
- No prior radiotherapy or chemotherapy
- No prior or concurrent full-dose anticoagulants or thrombolytics
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00408564
Start Date
January 1 2006
End Date
April 1 2013
Last Update
July 23 2018
Active Locations (1)
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1
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425