Phase I Study of Combination of Capecitabine and Erlotinib Concurrent With Radiotherapy in Patients With Non-Operable Locally Advanced Pancreatic Cancer
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine optimal dosage for Capecitabine and Tarceva combination in the setting of radiation.
Yixing Jiang, M.D.
Penn State College of Medicine
United States: Food and Drug Administration
|Penn State College of Medicine, Penn State Milton S. Hershey Medical Center||Hershey, Pennsylvania 17033|