A Phase I Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous CCI-779 Given Once Daily for 5 Days Every 2 Weeks to Patients With Advanced Solid Tumors
- Determine the safety, tolerability, and maximum tolerated dose (MTD) of CCI-779 in
patients with advanced solid tumors (part I) who are not receiving anticonvulsant
- Determine the safety, tolerability, and MTD in patients with recurrent gliomas or brain
metastases (part II) who are receiving anticonvulsant therapy.
- Determine the preliminary pharmacokinetic profile and antitumor activity of CCI-779 in
OUTLINE: This is an open-label, dose-escalation study.
- Part I: Patients receive CCI-779 IV over 30 minutes on days 1-5, followed by a 9 day
rest period. Treatment courses repeat every 2 weeks in the absence of disease
progression or unacceptable toxicity.
The maximum tolerated dose for part I is defined as the dose level at which 33% of patients
experience dose limiting toxicity.
- Part II: Patients receive the same treatment schedule as part I. Three patients with
CNS tumors are entered at the dose of CCI-779 determined to be the MTD in Part I. At
least 3 patients are entered at each dose level in part II.
PROJECTED ACCRUAL: Approximately 20 patients will be accrued for part I for this study
within 8 months, and 12 patients will be accrued for part II within 7 months.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Eric K. Rowinsky, MD
San Antonio Cancer Institute
United States: Food and Drug Administration
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|San Antonio Cancer Institute||San Antonio, Texas 78229-3264|