Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Cancer Institute (NCI)
With
PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose of UCN-01 (7-hydroxystaurosporine) and irinotecan (irinotecan hydrochloride) in patients with resistant solid tumors. (Part I \[closed to accrual as of 6/8/2007\]) II. Determine the dose-limiting toxicity of this regimen in these patients. (Part I \[closed to accrual as of 6/8/2007\]) III. Determine the types of toxic effects of this regimen in these patients. (Part I \[closed to accrual as of 6/8/2007\]) IV. Determine the anti-tumor activity in terms of overall response rate (partial response \[PR\] and complete response \[CR\]), clinical benefit rate (PR, CR, and stable disease), and time to disease progression in patients with estrogen receptor-negative, progesterone receptor-negative, and HER-2 not amplified (triple negative) locally recurrent or metastatic breast cancer treated with this regimen. (Part II) V. Determine the side effect profile of this regimen in patients with triple negative recurrent breast cancer. (Part II) SECONDARY OBJECTIVES: I. Determine any anti-tumor activity of this regimen in these patients. (Part I \[closed to accrual as of 6/8/2007\]) II. Determine the pharmacokinetics of this regimen in these patients. (Part I \[closed to accrual as of 6/8/2007\]) III. Determine the activity of the serum α-acid glycoprotein and correlate this level with free UCN-01 concentrations. (Part I \[closed to accrual as of 6/8/2007\]) IV. Determine the in vivo mechanisms of UCN-01 activity in these patients. OUTLINE: This is a dose-escalation study. PART I: Patients receive irinotecan hydrochloride intravenously (IV) over 90 minutes on days 1, 8, 15, and 22 and 7-hydroxystaurosporine IV over 3 hours on days 2 and 23. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan hydrochloride and 7-hydroxystaurosporine 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. Blood samples are collected periodically during study treatment. PART II: (treatment of triple negative recurrent breast cancer): Patients receive irinotecan hydrochloride IV and 7-hydroxystaurosporine IV as in part I at the MTD and undergo blood sample collection.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
