Cancer Clinical Trial
Official title:
Phase I Pharmacokinetic Trial of Thalidomide and Docetaxel: A Regimen Based on Anti-Angiogenic Therapeutic Principles
RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they
stop growing or die. Combining thalidomide with docetaxel may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining thalidomide with docetaxel in
treating patients who have advanced cancer.
OBJECTIVES:
- Determine the maximum tolerated dose of docetaxel when administered with thalidomide in
patients with advanced solid tumors, multiple myeloma, and non-Hodgkin's lymphoma.
- Determine the dose-limiting toxicity and safety profile of this regimen in these
patients.
- Determine the plasma pharmacokinetics of this regimen in these patients.
- Determine the objective tumor response and prolonged freedom from progression in
patients treated with this regimen.
OUTLINE: This is a dose-escalation study.
Patients receive oral thalidomide twice daily and docetaxel IV over 30 minutes once weekly.
Courses repeat every 12 weeks in the absence of disease progression or unacceptable
toxicity.
Cohorts of 3-6 patients receive escalating doses of docetaxel and thalidomide until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 1 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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