Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021073
Status:
COMPLETED
Last Update Posted:
2013-12-11
First Post:
2001-07-11
Brief Title:
Combination Chemotherapy in Treating Patients With Advanced Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of Flavopiridol in Combination With 5-Fluorouracil Leucovorin and Irinotecan in Patients With Advanced Malignancies
Status:
COMPLETED
Status Verified Date:
2013-12
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 flavopiridol fluorouracil and leucovorin with or without irinotecan in treating patients who have advanced cancer 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
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose of flavopiridol fluorouracil and leucovorin calcium with or without irinotecan in patients with advanced malignancy
II Assess the toxic effects of these regimens in these patients III Determine the clinical response in patients treated with these regimens
OUTLINE This a dose-escalation study of flavopiridol FLAVO fluorouracil 5-FU and irinotecan Patients are assigned to 1 of 2 groups Groups I and II are conducted sequentially
Group I Patients receive FLAVO IV over 24 hours on day 1 and leucovorin calcium CF IV and 5-FU IV over 15 hours daily on days 2-5 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of FLAVO and 5-FU until the maximum tolerated doses MTD are determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity
Group II Once the MTDs for FLAVO and 5-FU are determined patients receive FLAVO CF and 5-FU as in group I plus irinotecan IV over 15 hours on day 1 Courses repeat as in group I Cohorts of 3-6 patients receive escalating doses of irinotecan until the MTD is determined The MTD is defined as in group I
Patients are followed at 3 months
PROJECTED ACCRUAL A maximum of 57-90 patients will be accrued for this study within 18 months
I Determine the maximum tolerated dose of flavopiridol fluorouracil and leucovorin calcium with or without irinotecan in patients with advanced malignancy
II Assess the toxic effects of these regimens in these patients III Determine the clinical response in patients treated with these regimens
OUTLINE This a dose-escalation study of flavopiridol FLAVO fluorouracil 5-FU and irinotecan Patients are assigned to 1 of 2 groups Groups I and II are conducted sequentially
Group I Patients receive FLAVO IV over 24 hours on day 1 and leucovorin calcium CF IV and 5-FU IV over 15 hours daily on days 2-5 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of FLAVO and 5-FU until the maximum tolerated doses MTD are determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity
Group II Once the MTDs for FLAVO and 5-FU are determined patients receive FLAVO CF and 5-FU as in group I plus irinotecan IV over 15 hours on day 1 Courses repeat as in group I Cohorts of 3-6 patients receive escalating doses of irinotecan until the MTD is determined The MTD is defined as in group I
Patients are followed at 3 months
PROJECTED ACCRUAL A maximum of 57-90 patients will be accrued for this study within 18 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 |
|---|---|---|---|
| 2450 | OTHER | CTEP | None |
| NCI-2012-02389 | REGISTRY | None | None |
| CDR0000068745 | None | None | None |
| MAYO-MC0014 | None | None | None |
| NCI-2450 | None | None | None |
| MC0014 | OTHER | None | None |