Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00036777
Status:
COMPLETED
Last Update Posted:
2013-07-01
First Post:
2002-05-13
Brief Title:
UCN-01 and Carboplatin in Treating Patients With Advanced Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 1 Study of UCN-01 in Combination With Carboplatin in Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-06
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 carboplatin in treating patients who have advanced solid tumors UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining UCN-01 with carboplatin may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose dose limiting toxicity and other toxicities of UCN-01 when combined with carboplatin
II Preliminarily evaluate the antitumor effect of the combination of carboplatin and UCN-01
III Determine the pharmacokinetics of UCN-01 and carboplatin
OUTLINE This is a dose-escalation study
Patients receive carboplatin IV over 1 hour followed by UCN-01 IV over 3 hours on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of carboplatin and UCN-01 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
I Determine the maximum tolerated dose dose limiting toxicity and other toxicities of UCN-01 when combined with carboplatin
II Preliminarily evaluate the antitumor effect of the combination of carboplatin and UCN-01
III Determine the pharmacokinetics of UCN-01 and carboplatin
OUTLINE This is a dose-escalation study
Patients receive carboplatin IV over 1 hour followed by UCN-01 IV over 3 hours on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of carboplatin and UCN-01 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
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 |
|---|---|---|---|
| U01CA069854 | NIH | None | httpsreporternihgovquickSearchU01CA069854 |
| UMGCC 0143 | None | None | None |
| MSGCC-0143 | None | None | None |
| NCI-5533 | None | None | None |
| CDR0000069321 | None | None | None |