Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003690
Status:
COMPLETED
Last Update Posted:
2011-08-03
First Post:
1999-11-01
Brief Title:
Flavopiridol Plus Cisplatin or Carboplatin in Treating Patients With Advanced Solid Tumors
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Phase I Study of Flavopiridol in Combination With Cisplatin in Patients With Advanced Malignancies
Status:
COMPLETED
Status Verified Date:
2011-08
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:
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 flavopiridol plus cisplatin or carboplatin in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of flavopiridol plus cisplatin or carboplatin in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose MTD of flavopiridol and cisplatin in patients with advanced solid tumors Part 1
Determine the MTD of carboplatin when combined with flavopiridol in another group of patients with advanced solid tumors Part 2
Determine the toxic effects of these regimens in this patient population
Determine the objective clinical response in patients treated with this regimen
Determine the pharmacokinetics of these regimens in this patient population
OUTLINE This is a dose-escalation study of flavopiridol and cisplatin part 1 followed by a dose-escalation study of carboplatin part 2
Part 1 Patients receive flavopiridol IV over 24 hours Two weeks later patients receive cisplatin IV over 2 hours immediately followed by flavopiridol IV over 24 hours Treatment with cisplatinflavopiridol continues every 3 weeks in the absence of unacceptable toxicity or disease progression
Sequential dose escalation of flavopiridol is followed by sequential dose escalation of cisplatin Cohorts of 3-6 patients receive escalating doses of flavopiridol and then cisplatin until the maximum tolerated dose MTD of the combination is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity
Part 2 Additional patients are accrued for part 2 Those patients receive carboplatin IV over 30 minutes immediately followed by flavopiridol IV over 24 hours Treatment continues every 3 weeks in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of carboplatin until the MTD is determined The MTD is defined as in part 1
PROJECTED ACCRUAL Approximately 36-48 patients will be accrued for this study within 2 years
Determine the maximum tolerated dose MTD of flavopiridol and cisplatin in patients with advanced solid tumors Part 1
Determine the MTD of carboplatin when combined with flavopiridol in another group of patients with advanced solid tumors Part 2
Determine the toxic effects of these regimens in this patient population
Determine the objective clinical response in patients treated with this regimen
Determine the pharmacokinetics of these regimens in this patient population
OUTLINE This is a dose-escalation study of flavopiridol and cisplatin part 1 followed by a dose-escalation study of carboplatin part 2
Part 1 Patients receive flavopiridol IV over 24 hours Two weeks later patients receive cisplatin IV over 2 hours immediately followed by flavopiridol IV over 24 hours Treatment with cisplatinflavopiridol continues every 3 weeks in the absence of unacceptable toxicity or disease progression
Sequential dose escalation of flavopiridol is followed by sequential dose escalation of cisplatin Cohorts of 3-6 patients receive escalating doses of flavopiridol and then cisplatin until the maximum tolerated dose MTD of the combination is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity
Part 2 Additional patients are accrued for part 2 Those patients receive carboplatin IV over 30 minutes immediately followed by flavopiridol IV over 24 hours Treatment continues every 3 weeks in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients receive escalating doses of carboplatin until the MTD is determined The MTD is defined as in part 1
PROJECTED ACCRUAL Approximately 36-48 patients will be accrued for this study within 2 years
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 |
|---|---|---|---|
| 276-97 | OTHER | Mayo Clinic IRB | httpsreporternihgovquickSearchP30CA015083 |
| U01CA069912 | NIH | None | None |
| P30CA015083 | NIH | None | None |
| 950101 | OTHER | None | None |