3-AP Plus Cisplatin and Paclitaxel in Treating Patients With Advanced or Metastatic Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining 3-AP, cisplatin, and paclitaxel in treating patients who have advanced or metastatic cancer.
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: cisplatin Drug: paclitaxel Drug: triapine||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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|
|Study Start Date:||December 2000|
|Study Completion Date:||January 2008|
- 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 these patients.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00016874
|United States, New York|
|Albert Einstein Comprehensive Cancer Center|
|Bronx, New York, United States, 10461|
|New York Presbyterian Hospital - Cornell Campus|
|New York, New York, United States, 10021|
|Study Chair:||Mario Sznol, MD||Vion Pharmaceuticals|