Expired Study
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Aurora, Colorado 80045


Purpose:

Zactima will be used in this study to determine the highest dose that can be given safely as well as the side effects of Zactima when in combination with two FDA approved drugs; gemcitabine and capecitabine. This combination will be given to patients with advanced solid tumors. Once the highest dose of the combination has been determined, additional patients with biliary cancers (cholangiocarcinomas and gallbladder cancer) and locally advanced or metastatic pancreatic cancer will be treated at the highest determined dose for further studies.


Study summary:

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.


Criteria:

Inclusion Criteria: - Age 18 years or older - Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (measure of your ability to perform everyday tasks) - Life expectancy of at least three months Blood samples and other testing may apply for further testing of eligibility. Exclusion Criteria: - Uncontrolled illness (for example, current infections or heart conditions) - Abnormal laboratory tests (such as blood or urine testing) - Pregnant or breastfeeding women Further exclusion criteria may apply.


NCT ID:

NCT00551096


Primary Contact:

Principal Investigator
Stephen Leong, MD
University of Colorado, Denver


Backup Contact:

N/A


Location Contact:

Aurora, Colorado 80045
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

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