Phenoxodiol in Treating Patients With Refractory Solid Tumors
RATIONALE: Phenoxodiol may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: Phase I trial to study the effectiveness of phenoxodiol in treating patients who have refractory solid tumors.
Unspecified Adult Solid Tumor, Protocol Specific
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase IB Study of Phenoxodiol Given by Constant Intravenous Infusion in Patients With Solid Neoplasms (With the Exception of Breast Cancer) Whose Tumors Are Refractory to Standard Therapy|
|Study Start Date:||August 2001|
|Study Completion Date:||October 2007|
- Determine the maximum tolerated dose of phenoxodiol in patients with refractory solid tumors.
- Determine the steady-state pharmacokinetics of this drug in these patients.
- Determine the tumor response in patients treated with this drug.
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive phenoxodiol IV continuously over days 1-7. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of phenoxodiol 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.
Patients are followed at 4 weeks.
PROJECTED ACCRUAL: Approximately 18-36 patients will be accrued for this study.