Spots Global Cancer Trial Database for Warfarin and Vatalanib in Treating Patients With Advanced Solid Tumors

Study Description

Brief Summary: RATIONALE: Vatalanib may stop the growth of tumor cells by stopping blood flow to the tumor. Warfarin may be effective in preventing the formation of blood clots in patients who are undergoing treatment for advanced solid tumors. PURPOSE: This phase I trial is studying how well giving warfarin together with vatalanib works in treating patients with advanced solid tumors.

Detailed Description: OBJECTIVES: Primary * Determine the acute and chronic changes in INR in patients with advanced solid tumors treated with low-dose warfarin and vatalanib. Secondary * Determine the steady-state pharmacokinetics of this regimen in these patients. * Determine the safety and tolerability of this regimen in these patients. OUTLINE: This is a nonrandomized, open-label, multicenter study. * Pharmacokinetic (PK) phase: Patients receive oral low-dose warfarin once daily on days 1-14 and oral vatalanib once daily, 1 hour before warfarin administration, on days 2-14 in the absence of disease progression or unacceptable toxicity. * Continuation phase: Patients not experiencing a drug interaction in the PK phase continue to receive oral vatalanib and oral low-dose warfarin once daily. Patients experiencing a drug interaction (INR \> 2.0) in the PK phase receive oral vatalanib alone once daily. Continuation therapy continues indefinitely in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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