A Phase I Study of Gemcitabine, Capecitabine and ZD6474 (ZACTIMA) in Patients With Advanced Solid Tumors With an Expanded Cohort of Patients With Biliary or Pancreatic Malignancies.
This phase I study will access a novel regimen using a multi-targeted anti-angiogenic agent
which targets the tyrosine kinase of vascular endothelial growth factor (VEGF) receptor 2
and epidermal growth factor receptor (EGFR) in combination with cytotoxic agents:
gemcitabine and capecitabine. The rationale is based on observations that there is an
additive / synergistic effect when cytotoxic agents are combined with angiogenesis
inhibitors. There is also evidence that EGFR mediated signaling pathways are potent
stimulators of VEGF production. Also the concept of dual targeting of tumor and endothelial
cells may provide more encouraging results.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD) of ZACTIMA (ZD6474) in combination with Gemcitabine and Capecitabine
To evaluate the safety profile and determine the MTD dose of ZACTIMA in combination with Gemcitabine and Capecitabine in patients with advanced malignancies. Toxicity will be graded per Common Toxicity Criteria for Adverse Effects (CTCAE) Version 3.0 and adverse event reporting for this study will be performed via Adverse Event Expedited Reporting System (AdEERS). All patients who receive any amount of the study drug will be evaluable for toxicity.
Up to 28 days
Stephen Leong, MD
University of Colorado, Denver
United States: Food and Drug Administration
|University of Colorado Denver||Denver, Colorado 80262|