NCT00788580

S0718 Pazopanib and Temsirolimus in Treating Patients With Advanced Solid Tumors

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	pazopanib hydrochloride
DRUG	temsirolimus
PROCEDURE	immunoenzyme technique
PROCEDURE	laboratory biomarker analysis
PROCEDURE	pharmacological study

Timeline

• First posted: 2008-11-11
• Last updated: 2015-03-06