Combination Study of Capecitabine and Erlotinib Concurrent With Radiotherapy for Non-Operable Advanced Pancreatic Cancer

• Status: Completed
• Trial end date: 2014-08-05
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Milton S. Hershey Medical Center; Penn State University
• Collaborator: Genentech, Inc.
• Treatments: Capecitabine; Erlotinib Hydrochloride

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.