NCT00303732

Vatalanib and Everolimus in Treating Patients With Advanced Solid Tumors

PTK787/ZK222584 and RAD001 for Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Daniel George, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Vatalanib and everolimus may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of vatalanib and everolimus and to see how well they work in treating patients with advanced solid tumors.

Detailed description

OBJECTIVES: Primary * Determine the maximum tolerated dose (MTD) of vatalanib and everolimus in patients with advanced solid tumors. * Determine the safety and tolerability of vatalanib and everolimus in patients with advanced solid tumors. * Evaluate the safety and tolerability of vatalanib and everolimus at the MTD in patients with metastatic renal cell carcinoma (RCC). Secondary * Describe the non dose-limiting toxic effects associated with vatalanib and everolimus. * Describe the pharmacokinetics of vatalanib and everolimus in patients with advanced solid tumors. * Determine the functional extent of mTOR inhibition by changes in the phosphorylation status of S6K protein in peripheral blood mononuclear cells in patients treated with vatalanib and everolimus. * Describe any clinical responses seen in patients with metastatic RCC in a dose-expansion cohort treated at the MTD. * Observe overall survival of RCC patients treated with vatalanib and everolimus. * Determine the time to progression of patients with RCC treated with vatalanib and everolimus. OUTLINE: This is a phase I dose-escalation study followed by a phase Ib study. * Phase I (solid tumors): Patients receive oral vatalanib on days 1-28 and oral everolimus on days 15-28 during course 1 and on days 1-28 during all subsequent courses. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of vatalanib and everolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. * Phase Ib (renal cell carcinoma only): Patients receive oral vatalanib and oral everolimus at the MTD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months. PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.

Conditions

• Kidney Cancer
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	RAD001 (everolimus)
DRUG	PTK787 (vatalanib)

Timeline

• Start date: 2004-12-01
• Primary completion: 2010-08-01
• Completion: 2012-08-01
• First posted: 2006-03-17
• Last updated: 2016-03-03

Locations

1 site across 1 country: United States