Phase I Trial of Weekly Docetaxel and Daily Temozolomide in Patients With Metastatic Disease
OBJECTIVES:
Primary
- Determine the toxicity profile, dose-limiting toxicity, and maximum tolerated dose of
docetaxel and temozolomide (TMZ) in patients with metastatic cancer.
Secondary
- Determine the activity of docetaxel and TMZ in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive docetaxel IV over 1 hour on days 1, 8, and 15 and oral temozolomide once
daily on days 1-21. Treatment repeats every 28 days for up to 1 year in the absence of
unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of docetaxel and temozolomide until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A total of 6
patients receive treatment at the MTD.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose
4 cycles
Yes
Ronald M. Bukowski, MD
Study Chair
The Cleveland Clinic
United States: Federal Government
CASE-CCF-4737
NCT00401180
June 2002
July 2008
Name | Location |
---|---|
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |