3-AP Plus Cisplatin and Paclitaxel in Treating Patients With Advanced or Metastatic Cancer
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
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
Albert Einstein Comprehensive Cancer Center🇺🇸Bronx, New York, United States