Breast Cancer Clinical Trial
Official title:
Phase I Study of the Pharmacokinetics and Pharmacodynamics of ZD6474 in Combination With Docetaxel in Advanced Solid Tumors
RATIONALE: Vandetanib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,
such as docetaxel, work in different ways to stop the growth of tumor cells, either by
killing the cells or by stopping them from dividing. Giving vandetanib together with
docetaxel may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vandetanib given
together with docetaxel in treating patients with advanced solid tumors.
OBJECTIVES:
Primary
- To investigate the differential biological effects in tumor tissues through
pharmacodynamic endpoints (percent inhibition of pERK, pKDR, and pEGFR) and their
correlation with pharmacokinetics of vandetanib in combination with docetaxel in
patients with advanced solid tumors.
- To correlate the pharmacodynamic endpoints with the pharmacokinetics of this
combination regimen in these patients.
- To recommend an optimal biological dose of this combination regimen for further
testing.
Secondary
- To correlate the pharmacokinetics with safety profiles of two dose levels of vandetanib
when given in combination with docetaxel.
- To investigate scientific correlates, including serum proteomics and microvessel
density (CD31) and cell death (TUNEL) using tumor tissue biopsy samples taken at
baseline and during treatment.
- To determine the objective response in patients with measurable disease at baseline.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour on day 1 and oral vandetanib once daily on days
1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable
toxicity. After 6 weeks of treatment, patients who experience clinical benefit but poor
tolerance to docetaxel may continue treatment with vandetanib alone.
Plasma samples are collected periodically for pharmacokinetic analysis, measurement of
vandetanib trough levels, serum biomarker analysis, and serum proteomics. Tumor tissue
samples are collected at baseline and once between days 36-38 for pharmacodynamic analysis.
After completion of study treatment, patients are followed up for up to 28 days.
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