Status:
COMPLETED
Cetuximab, Gemcitabine, and Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Lead Sponsor:
University of Miami
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-120 years
Phase:
NA
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 of patients with locally advanced or metastatic pancreatic cancer treated with cetuximab, gemcitabine hydrochloride, and oxaliplatin. S...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed pancreatic cancer
- Locally advanced or metastatic disease
- No active CNS metastases
- Patients with stable CNS disease, who have undergone radiotherapy within the past 4 weeks and who have been on a stable dose of corticosteroids for \> 3 weeks, are eligible
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Bilirubin ≤ 1.5 mg/dL
- Alkaline phosphatase ≤ 3 times upper limit of normal (ULN) (5 times ULN if known hepatic metastases)
- AST and ALT ≤ 3 times ULN (5 times ULN if known hepatic metastases)
- Creatinine ≤ 1.5 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 90 days after completion of study treatment
- No significant history of uncontrolled cardiac disease, including 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 infection or fever ≥ 38.5°C within the past 3 days
- No known hypersensitivity to any components of gemcitabine hydrochloride, oxaliplatin, or to a monoclonal antibody
- No peripheral neuropathy ≥ grade 2
- No known HIV positivity
- No hepatitis B or C infection (active, previously treated, or both)
- No other medical condition, including mental illness or substance abuse, that would preclude study compliance
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from all prior therapy, including surgery
- More than 30 days since prior investigational therapy
- More than 4 weeks since prior radiotherapy
- No prior radiotherapy to more than 25% of bone marrow
- More than 30 days since prior chemotherapy
- No prior chemotherapy for metastatic pancreatic cancer
- Prior fluoropyrimidine as a radiosensitizer allowed
- Prior gemcitabine hydrochloride in the adjuvant setting allowed
- No prior therapy that specifically and directly targets the epidermal growth factor receptor (EGFR) pathway
- No prior allogeneic transplantation
- No other concurrent investigational therapy, chemotherapy, or systemic antineoplastic therapy
- No other concurrent treatment that targets the EGFR
- No other concurrent monoclonal antibody therapy
- No concurrent radiotherapy except for local control of bone pain
Exclusion
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00448838
Start Date
May 1 2006
End Date
March 1 2011
Last Update
December 15 2016
Active Locations (1)
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1
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136