Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003331
Status:
COMPLETED
Last Update Posted:
2011-03-28
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Advanced Cancer
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
A Phase I Study of Low Dose Continuous Infusion Topotecan in Combination With 5-Fluorouracil and Leucovorin for Advanced Malignancies
Status:
COMPLETED
Status Verified Date:
2011-03
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 combining topotecan fluorouracil and leucovorin in treating patients who have advanced cancer
PURPOSE Phase I trial to study the effectiveness of combining topotecan fluorouracil and leucovorin in treating patients who have advanced cancer
Detailed Description:
OBJECTIVES I Evaluate the maximum tolerated dose MTD of continuous infusion topotecan in combination with fluorouracil for patients with advanced malignancy and establish a recommended phase II dose based on the MTD II Evaluate the dose limiting toxicity of this combination in these patients II Obtain pharmacokinetic and pharmacodynamic data for topoisomerase-1 depletion in patients receiving this treatment IV Identify any objective tumor responses arising from this treatment in these patients
OUTLINE This is a dose-escalation study of topotecan in combination with fluorouracil Patients receive topotecan as a 24-hour continuous infusion on days 1-14 in combination with fluorouracil IV and leucovorin calcium IV on days 1-5 course repeats every 4 weeks Treatment continues in the absence of unacceptable toxicity or disease progression In the absence of dose limiting toxicity DLT in the first cohort of 3 patients treated subsequent cohorts each receive escalating doses on the same schedule If DLT is observed in 2 of 3 patients or 2 of 6 patients at a given dose level then dose escalation ceases and the next lower dose is declared the maximum tolerated dose
PROJECTED ACCRUAL Approximately 6-30 patients will be accrued for this study
OUTLINE This is a dose-escalation study of topotecan in combination with fluorouracil Patients receive topotecan as a 24-hour continuous infusion on days 1-14 in combination with fluorouracil IV and leucovorin calcium IV on days 1-5 course repeats every 4 weeks Treatment continues in the absence of unacceptable toxicity or disease progression In the absence of dose limiting toxicity DLT in the first cohort of 3 patients treated subsequent cohorts each receive escalating doses on the same schedule If DLT is observed in 2 of 3 patients or 2 of 6 patients at a given dose level then dose escalation ceases and the next lower dose is declared the maximum tolerated dose
PROJECTED ACCRUAL Approximately 6-30 patients will be accrued for this study
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 |
|---|---|---|---|
| P30CA016087 | NIH | None | None |
| NYU-9752 | None | None | None |
| NCI-G98-1421 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016087 |