Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002902
Status:
COMPLETED
Last Update Posted:
2019-03-13
First Post:
1999-11-01
Brief Title:
Irinotecan Plus ICI D1694 in Treating Patients With Advanced Solid Tumors
Sponsor:
Abramson Cancer Center at Penn Medicine
Organization:
Abramson Cancer Center at Penn Medicine
Study Overview
Official Title:
PHASE I TRIAL OF IRINOTECAN AND TOMUDEX IN COMBINATION ON AN EVERY THREE WEEK SCHEDULE
Status:
COMPLETED
Status Verified Date:
2002-07
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 plus ICI D1694 in treating patients with advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of irinotecan plus ICI D1694 in treating patients with advanced solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of ICI D1694 TDX when given with irinotecan CPT-11 every 3 weeks in patients with advanced solid malignancies II Describe the pharmacokinetics of TDX and CPT-11 when given in combination III Investigate the relationship between topoisomerase I expression in peripheral mononuclear cells and myelosuppression andor gastrointestinal toxicity IV Investigate the effect of CPT-11 on thymidylate synthase expression in tumor
OUTLINE This is a dose-escalating study to determine the maximum tolerated dose MTD of ICI D1694 TDX given in combination with irinotecan Irinotecan is given intravenously on day 1 and ICI D1694 intravenously on day 2 Treatment is repeated every 3 weeks until disease progression or unacceptable toxicity intervenes Cohorts of 3-6 patients receive escalated doses of TDX until the MTD is defined an additional 10-12 patients will be entered at the MTD to confirm this as a recommended phase II dose
PROJECTED ACCRUAL 30-35 patients will be entered
OUTLINE This is a dose-escalating study to determine the maximum tolerated dose MTD of ICI D1694 TDX given in combination with irinotecan Irinotecan is given intravenously on day 1 and ICI D1694 intravenously on day 2 Treatment is repeated every 3 weeks until disease progression or unacceptable toxicity intervenes Cohorts of 3-6 patients receive escalated doses of TDX until the MTD is defined an additional 10-12 patients will be entered at the MTD to confirm this as a recommended phase II dose
PROJECTED ACCRUAL 30-35 patients will be entered
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-T96-0063O | None | None | None |
| UPCC-T96-0063 | None | None | None |
| JMC-T96-0063 | None | None | None |