3-AP Plus Cisplatin and Paclitaxel in Treating Patients With Advanced or Metastatic Cancer

Phase 1

Completed

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00016874
• Lead Sponsor: Vion Pharmaceuticals

Brief 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, cisplatin, and paclitaxel in treating patients who have advanced or metastatic cancer.

Detailed Description

OBJECTIVES:

* 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 Timeline

• Study Start: 2000-12
• Study First Submitted: 2001-06-06
• Study First Submitted QC: 2003-09-08
• Study First Posted: 2003-09-09
• Status Verified: 2007-12
• Study Completion: 2008-01
• Last Update Submitted: 2013-07-17
• Last Update Posted: 2013-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

Albert Einstein Comprehensive Cancer Center; 🇺🇸 Bronx, New York, United States

New York Presbyterian Hospital - Cornell Campus; 🇺🇸 New York, New York, United States