UCN-01 and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00006464|
Recruitment Status : Completed
First Posted : May 30, 2003
Last Update Posted : January 15, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: 7-hydroxystaurosporine Drug: cisplatin||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase I Dose Escalation Study of UCN-01 (NSC 638850) Plus Cisplatin in Advanced Malignant Solid Tumors|
|Study Start Date :||March 2001|
|Actual Primary Completion Date :||January 2005|
|Actual Study Completion Date :||June 2008|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|