Combination Chemotherapy in Treating Patients With Advanced Cancer
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Registration Number
- NCT00024323
- 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 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.
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)
Arizona Clinical Research Center
🇺🇸Tucson, Arizona, United States
Yale Comprehensive Cancer Center
🇺🇸New Haven, Connecticut, United States