Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012194
Status:
TERMINATED
Last Update Posted:
2013-07-09
First Post:
2001-03-03
Brief Title:
7-hydroxystaurosporine and Cisplatin in Treating Patients With Advanced Malignant Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Dose Escalation Study of UCN-01 NSC 638850 Plus Cisplatin in Advanced Malignant Solid Tumors
Status:
TERMINATED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase I trial to study the effectiveness of combining UCN-01 with cisplatin in treating patients who have advanced solid tumors Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth and may help cisplatin kill more cancer cells by making tumor cells more sensitive to the drug
Detailed Description:
OBJECTIVES
I To establish the maximum tolerated dose MTD of cisplatin in combination with UCN-01 in patients with advanced malignancies
II To assess the toxicity and observe the potential antitumor activity of UCN-01 plus cisplatin in advanced malignancies at each dose level studies
III To determine the pharmacokinetics of UCN-01 and cisplatin on this treatment schedule
IV To perform laboratory correlative studies to investigate intermediate molecular markers of the activity of UCN-01 and cisplatin at the cellular level
OUTLINE This is a dose-escalation study of cisplatin
Patients receive cisplatin IV over 1 hour on day 1 and UCN-01 IV continuously over 36-72 hours on day 2 Treatment repeats every 4 weeks for up to 6 courses 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 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 2-3 months for at least 1 year
I To establish the maximum tolerated dose MTD of cisplatin in combination with UCN-01 in patients with advanced malignancies
II To assess the toxicity and observe the potential antitumor activity of UCN-01 plus cisplatin in advanced malignancies at each dose level studies
III To determine the pharmacokinetics of UCN-01 and cisplatin on this treatment schedule
IV To perform laboratory correlative studies to investigate intermediate molecular markers of the activity of UCN-01 and cisplatin at the cellular level
OUTLINE This is a dose-escalation study of cisplatin
Patients receive cisplatin IV over 1 hour on day 1 and UCN-01 IV continuously over 36-72 hours on day 2 Treatment repeats every 4 weeks for up to 6 courses 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 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 2-3 months for at least 1 year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2331 | None | None | None |
| DMS 9934 | None | None | None |
| DMS-9934 | None | None | None |