NCT00024323

Combination Chemotherapy in Treating Patients With Advanced Cancer

A Phase I Study of 3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone (3-AP, Triapine) Administered Daily x 5 in Combination With Cisplatin

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Vion Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	triapine

Timeline

• Start date: 2001-03-01
• Completion: 2003-06-01
• First posted: 2003-06-20
• Last updated: 2013-07-18

Locations

2 sites across 1 country: United States