Sorafenib and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Completed · Phase 2
Conditions studied: Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage II Pancreatic Cancer, Stage III Pancreatic Cancer, Stage IV Pancreatic Cancer
In brief
Sorafenib may stop the growth of tumor cells by stopping blood flow to the tumor and by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving sorafenib with gemcitabine may kill more tumor cells. This phase II trial is studying how well giving sorafenib together with gemcitabine works in treating patients with locally advanced or metastatic pancreatic cancer.
Key facts
- Study ID
- NCT00095966
- Run by
- National Cancer Institute (NCI)
- People needed
- 35
- Starts
- 2004-09-01
- Last updated by the study team
- 2013-07-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically confirmed adenocarcinoma of the pancreas
- Locally advanced or metastatic disease
- Locally advanced disease must extend outside the boundaries of a standard radiotherapy port
- Not amenable to curative surgery or radiotherapy
- Measurable disease
- At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- Pleural effusion and ascites are not considered measurable lesions
- Outside prior radiotherapy port
- No known brain metastases
- Performance status - ECOG 0-1
- Performance status - Karnofsky 70-100%
- More than 3 months
- WBC ≥ 3,000/mm\^3
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- No evidence of bleeding diathesis
- Bilirubin normal
- AST and/or ALT ≤ 2.5 times upper limit of normal
- Creatinine normal
- Creatinine clearance ≥ 60 mL/min
- No uncontrolled hypertension
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- Not pregnant or nursing
Where it is running
- University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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