A Phase I Study Of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP, Triapine) In Combination With Cisplatin And Paclitaxel In Patients With Advanced And Metastatic Cancer
- Determine the safety and tolerability of 3-AP, cisplatin, and paclitaxel in patients
with advanced or metastatic cancer.
- Determine the toxic effects of this regimen in these patients.
- Determine the maximum tolerated dose and recommended phase II dose of this regimen in
- Determine the pharmacokinetic parameters of this regimen in these patients.
- Determine the tumor response in patients treated with this regimen.
OUTLINE: This is a dose-escalation study.
Patients receive 3-AP IV continuously over 96 hours on days 1-4 and paclitaxel IV over 3
hours followed by cisplatin IV over 1 hour on day 3. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity. Patients achieving complete
response (CR) receive 1 additional course of therapy after documented CR. Patients with
partial response or stable disease may receive therapy for up to 6 months.
Cohorts of 1-6 patients receive escalating doses of 3-AP, paclitaxel, and cisplatin until
the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding
that at which 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: Approximately 25-30 patients will be accrued for this study.
Primary Purpose: Treatment
Mario Sznol, MD
United States: Federal Government
|Albert Einstein Comprehensive Cancer Center||Bronx, New York 10461|
|New York Presbyterian Hospital - Cornell Campus||New York, New York 10021|