Combination Chemotherapy in Treating Patients With Advanced 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 with cisplatin in treating patients who have advanced cancer.
Unspecified Adult Solid Tumor, Protocol Specific
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Study of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP, Triapine) Administered Daily x 5 in Combination With Cisplatin|
|Study Start Date:||March 2001|
|Study Completion Date:||June 2003|
- Determine the maximum tolerated dose of cisplatin when administered with 3-AP in patients with advanced cancer.
- Determine the toxic effects of this regimen in these patients.
- Determine the antitumor responses in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of cisplatin.
Patients receive 3-AP IV over 2 hours on days 1-4 and cisplatin IV over 1 hour on days 2 and 3. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of 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: A total of 15-25 patients will be accrued for this study.
|United States, Arizona|
|Arizona Clinical Research Center|
|Tucson, Arizona, United States, 85712|
|United States, Connecticut|
|Yale Comprehensive Cancer Center|
|New Haven, Connecticut, United States, 06520-8028|
|Study Chair:||Mario Sznol, MD||Vion Pharmaceuticals|