Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003867
Status:
COMPLETED
Last Update Posted:
2018-09-10
First Post:
1999-11-01
Brief Title:
Irinotecan and Capecitabine in Treating Patients With Solid Tumors
Sponsor:
Montefiore Medical Center
Organization:
Montefiore Medical Center
Study Overview
Official Title:
Phase I Clinical Study of Every Three Week Irinotecan With Oral Capecitabine Given Twice Daily for Two Weeks Out of Three in Patients With Gastrointestinal and Other Solid Malignancies
Status:
COMPLETED
Status Verified Date:
2018-09
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 irinotecan and capecitabine in treating patients who have solid tumors that have not responded to previous treatment
PURPOSE Phase I trial to study the effectiveness of irinotecan and capecitabine in treating patients who have solid tumors that have not responded to previous treatment
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose and toxic effects of irinotecan and oral capecitabine in patients with gastrointestinal or other solid tumors II Characterize the relationship at the recommended phase II dose between thymidine synthase and thymidine phosphorylase expression and tumor response andor toxic effects in these patients
OUTLINE This is a dose escalation study Patients receive oral capecitabine twice daily every twelve hours for 14 days and IV irinotecan over 30 minutes once every 3 weeks beginning on day 1 Treatment continues for at least 2 courses in the absence of disease progression or unacceptable toxicity The dose of capecitabine and irinotecan is escalated in cohorts of 3-6 patients until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity
PROJECTED ACCRUAL Approximately 25-30 patients will be accrued for this study
OUTLINE This is a dose escalation study Patients receive oral capecitabine twice daily every twelve hours for 14 days and IV irinotecan over 30 minutes once every 3 weeks beginning on day 1 Treatment continues for at least 2 courses in the absence of disease progression or unacceptable toxicity The dose of capecitabine and irinotecan is escalated in cohorts of 3-6 patients until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicity
PROJECTED ACCRUAL Approximately 25-30 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 |
|---|---|---|---|
| NCI-V99-1541 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA013330 |
| P30CA013330 | NIH | None | None |
| AECM-1199903068 | None | None | None |