Vatalanib and Everolimus in Treating Patients With Advanced Solid Tumors — PTK/RAD  

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title: PTK787/ZK222584 and RAD001 for Patients With Advanced Solid Tumors

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Cancer
• Unspecified Adult Solid Tumor, Protocol Specific

• NCT number: NCT00303732
• Study type: Interventional
• Source: Duke University
• Status: Completed
• Phase: Phase 1
• Start date: December 2004
• Completion date: August 2012