S0718 Pazopanib and Temsirolimus in Treating Patients With Advanced Solid Tumors
RATIONALE: Pazopanib and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Pazopanib may also blocking blood flow to the tumor. Giving pazopanib together with temsirolimus may be an effective treatment for advanced solid tumors.
PURPOSE: This phase I trial is studying the side effects and best dose of temsirolimus when given together with pazopanib in treating patients with advanced solid tumors.
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: pazopanib hydrochloride Drug: temsirolimus Procedure: immunoenzyme technique Procedure: laboratory biomarker analysis Procedure: pharmacological study||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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|
- Safety as assessed by NCI CTCAE v3.0
- Feasibility of the drug combination
- Maximum tolerated dose of temsirolimus in combination with pazopanib
- Pharmacokinetics of temsirolimus alone and in combination with pazopanib
- Relevant biological markers
- Objective response as assessed by RECIST criteria
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00788580
|Principal Investigator:||Claire F. Verschraegen, MD||University of New Mexico Cancer Center|