S0718: Phase I Study Evaluating The Combination of GW786034 (Pazopanib; NSC-737754; IND-XXXX) and CCI-779 (Temsirolimus; NSC-683864; IND-XXXX) in Patients With Advanced Solid Tumors
OBJECTIVES:
- To investigate the safety and feasibility of temsirolimus and pazopanib when given in
combination in patients with advanced solid tumors.
- To recommend the maximum tolerated dose of this regimen in these patients.
- To investigate the pharmacokinetics of temsirolimus alone and in combination with
pazopanib in these patients.
- To investigate the effects of this regimen on relevant biological markers.
- To preliminarily report objective response in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive temsirolimus IV over 30 minutes on days 1, 8,15, and 22 and oral pazopanib
hydrochloride once daily on days 4-28 in course 1 and days 1-28 in all subsequent courses.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blood samples are obtained periodically for evaluation of the pharmacokinetics of
temsirolimus and pazopanib, plasma and serum angiogenic and cachectic factors (e.g., VEGF,
bFGF, PlGF and SDF-1) by enzyme-linked immunosorbent assay, and biological markers in the
mTOR/PI3/Akt, Ras/MAPK, VEGFR, PDGFR, and HIF-1 pathways.
After completion of study therapy, patients are followed for 28 days.
Interventional
Primary Purpose: Treatment
Safety as assessed by NCI CTCAE v3.0
Yes
Claire F. Verschraegen, MD
Principal Investigator
University of New Mexico Cancer Center
United States: Food and Drug Administration
CDR0000619343
NCT00788580
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