UCN-01 and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors
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.
Unspecified Adult Solid Tumor, Protocol Specific
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Dose Escalation Study of UCN-01 (NSC 638850) Plus Cisplatin in Advanced Malignant Solid Tumors|
|Study Start Date:||March 2001|
|Study Completion Date:||June 2008|
|Primary Completion Date:||January 2005 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006464
|United States, California|
|USC/Norris Comprehensive Cancer Center and Hospital|
|Los Angeles, California, United States, 90033-0804|
|City of Hope Medical Group|
|Pasadena, California, United States, 91105|
|University of California Davis Cancer Center|
|Sacramento, California, United States, 95817|
|United States, New Hampshire|
|Norris Cotton Cancer Center|
|Lebanon, New Hampshire, United States, 03756-0002|
|Study Chair:||David R. Gandara, MD||University of California, Davis|