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Brief Title: Combination Study of Capecitabine and Erlotinib Concurrent With Radiotherapy for Non-Operable Advanced Pancreatic Cancer
Official Title: Phase I Study of Combination of Capecitabine and Erlotinib Concurrent With Radiotherapy in Patients With Non-Operable Locally Advanced Pancreatic Cancer
Study ID: NCT00565487
Brief 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.
Detailed Description: Over the past several decades, 5-fluorouracil based chemoradiation has been the cornerstone for the treatment of locally advanced non-operable pancreatic cancer. However, the survival of these patients is disappointing. The majority of the patients suffer either local progression or metastatic disease. With the availability of Capecitabine, a few pilot studies showed the the drug is convenient, tolerable and safe in combination with radiation therapy. Capecitabine demonstrated its superior anti-tumor activity with 14 months of median survival. However, these are small Phase I studies and the survival benefit needs to be further validated with larger studies. Epidermal growth factor receptor (EGFR) has been implicated in tumor growth and angiogenesis. Inhibiting EGFR by Tarceva has demonstrated effective treatment in metastatic pancreatic cancer. Anti-epidermal growth factor therapy in combination with radiotherapy has been demonstrated efficacious in other solid tumors such as head and neck cancer. We hypothesize that the combination of Tarceva and Capecitabine has synergistic anti-tumor effect. Hence, improvement of median survival could be potentially achieved with this novel combination.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Name: Yixing Jiang, M.D.
Affiliation: Penn State College of Medicine
Role: PRINCIPAL_INVESTIGATOR