UCN-01 and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Registration Number
- NCT00006464
- Lead Sponsor
- City of Hope Medical Center
- 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 UCN-01 and cisplatin in treating patients who have advanced or metastatic solid tumors.
- Detailed Description
OBJECTIVES:
* Determine the maximum tolerated dose of cisplatin when administered with UCN-01 in patients with advanced solid tumors.
* Assess the toxicity and potential antitumor activity of this regimen in these patients.
* Determine the pharmacokinetics of this regimen in these patients.
OUTLINE: This is a dose-escalation, multicenter study of cisplatin.
Patients receive cisplatin IV over 1 hour on day 1 and UCN-01 IV continuously over 36-72 hours beginning on day 2. Treatment continues every 4 weeks for a total of 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 1-6 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 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed every 2-3 months for at least 1 year.
PROJECTED ACCRUAL: A total of 9-30 patients will be accrued for this study within 1 year.
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 (4)
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
City of Hope Medical Group
🇺🇸Pasadena, California, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
USC/Norris Comprehensive Cancer Center and Hospital🇺🇸Los Angeles, California, United States