Combination Study of Capecitabine and Erlotinib Concurrent With Radiotherapy for Non-Operable Advanced Pancreatic Cancer
Completed · Phase 1
Conditions studied: Pancreatic Cancer
In brief
The primary purpose of this study is to determine the best dosage of Capecitabine and Tarceva combination in the setting of radiation and to assess treatment effectiveness, progression-free survival and overall survival.
Key facts
- Study ID
- NCT00565487
- Run by
- Milton S. Hershey Medical Center
- People needed
- 15
- Starts
- 2007-12-01
- Expected to finish
- 2014-08-05
- Last updated by the study team
- 2018-05-21
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologic or cytologic diagnosis of adenocarcinoma of the pancreas that is locally advanced \& not amenable to resection with curative intent.
- Must not have received prior systemic therapy for locally advanced disease.
- ECOG performance status must be 0-2.
- Adequate hepatic, renal \& bone marrow function.
- Radiographic evidence of disease is required.
- Life expectancy > 12 weeks.
You may not qualify if…
- Prior treatment with Capecitabine \& other EGFR inhibitor.
- Patients with GI tract disease resulting in an inability to take oral medications.
- Significant GI disorders with diarrhea as a major symptom.
- Uncontrolled intercurrent illness including active infection,symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmias now well controlled with medication, myocardial infarction within the previous 6 months, psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with metastases.
- Patients who have had chemotherapy.
- Patients may not be receiving any other investigational agents, or have participated in any investigational drug study.
- Extensive symptomatic fibrosis of the lungs.
- Females who are pregnant or lactating.
- History of any other malignancy in the last 2 years, except prior history of in situ cancer, basal or squamous cell skin cancer are eligible.
- Known DPD deficiency.
- Receiving therapeutic doses of Coumarin-derivative anticoagulant therapy. Patients requiring anticoagulation who may be safely switched to LMWH are eligible.
Where it is running
- Penn State College of Medicine, Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
Full record on ClinicalTrials.gov
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