Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00042874
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2002-08-05
Brief Title:
Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
An Open-Labeled Non-Randomized Phase I Study of Alvocidib Flavopiridol Administered With Irinotecan CPT-11 and FluorouracilLeucovorin in Patients With 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:
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 This phase I trial is studying the side effects and best dose of combination chemotherapy in treating patients with locally advanced or metastatic solid tumors
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose of flavopiridol alvocidib when administered with irinotecan hydrochloride fluorouracil and leucovorin calcium in patients with locally advanced or metastatic solid tumors
II Determine the clinical pharmacokinetics of fluorouracil when administered in this regimen in these patients
III Determine preliminarily the therapeutic activity of this regimen in these patientsCorrelate the role of p21 and Drg1 with apoptosis and treatment response in patients receiving this regimen
OUTLINE This is a dose-escalation study of alvocidib and fluorouracil 5-FU
Patients receive irinotecan hydrochloride IV over 90 minutes followed 5 hours later by leucovorin calcium IV over 2 hours and alvocidib IV over 1 hour immediately followed by 5-FU IV continuously over 48 hours beginning on day 1 of weeks 1 3 and 5 Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of alvocidib and 5-FU 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 Ten additional patients are treated at the MTD
PROJECTED ACCRUAL A total of 27-77 patients will be accrued for this study within 11-38 months
I Determine the maximum tolerated dose of flavopiridol alvocidib when administered with irinotecan hydrochloride fluorouracil and leucovorin calcium in patients with locally advanced or metastatic solid tumors
II Determine the clinical pharmacokinetics of fluorouracil when administered in this regimen in these patients
III Determine preliminarily the therapeutic activity of this regimen in these patientsCorrelate the role of p21 and Drg1 with apoptosis and treatment response in patients receiving this regimen
OUTLINE This is a dose-escalation study of alvocidib and fluorouracil 5-FU
Patients receive irinotecan hydrochloride IV over 90 minutes followed 5 hours later by leucovorin calcium IV over 2 hours and alvocidib IV over 1 hour immediately followed by 5-FU IV continuously over 48 hours beginning on day 1 of weeks 1 3 and 5 Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of alvocidib and 5-FU 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 Ten additional patients are treated at the MTD
PROJECTED ACCRUAL A total of 27-77 patients will be accrued for this study within 11-38 months
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 |
|---|---|---|---|
| U01CA069856 | NIH | None | httpsreporternihgovquickSearchU01CA069856 |
| 5757 | None | None | None |
| NCI-5757 | None | None | None |
| CDR0000069479 | None | None | None |
| MSKCC-02024 | None | None | None |