3-AP Plus Cisplatin and Paclitaxel in Treating Patients With Advanced or Metastatic Cancer
|ClinicalTrials.gov Identifier: NCT00016874|
Recruitment Status : Completed
First Posted : September 9, 2003
Last Update Posted : July 18, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: cisplatin Drug: paclitaxel Drug: triapine||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|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|
|Actual Study Completion Date :||January 2008|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|