Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003711
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Metastatic Solid Tumors
Sponsor:
San Antonio Cancer Institute
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial of LY231514 With Irinotecan Administered Intravenously Every 21 Days in Patients With Metastatic Cancer
Status:
COMPLETED
Status Verified Date:
2000-04
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 combination chemotherapy with pemetrexed disodium and irinotecan in treating patients who have metastatic solid tumors
PURPOSE Phase I trial to study the effectiveness of combination chemotherapy with pemetrexed disodium and irinotecan in treating patients who have metastatic solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of LY231514 followed by irinotecan in patients with metastatic cancer II Determine the quantitative and qualitative toxicity of LY231514 in combination with irinotecan in these patients III Assess plasma pharmacokinetics in these patients treated with this regimen IV Document any antitumor activity of this regimen in these patients
OUTLINE This is a dose escalation study Patients receive LY231514 IV over 10 minutes followed by irinotecan IV over 90 minutes on day 1 Courses repeat every 3 weeks in the absence of disease progression and unacceptable toxicity Cohorts of 3-6 patients each receive escalating doses of LY231514 and irinotecan If escalation of one drug in the combination results in unacceptable dose limiting toxicity DLT the drug is not escalated further Instead the dose of that drug is decreased to its safe dose and the second drug is escalated until unacceptable DLT results If DLT occurs in 2 of up to 6 patients at any level dose escalation is stopped The maximum tolerated dose is defined as the highest dose at which fewer than 2 of 6 patients experience DLT during courses 1 or 2
PROJECTED ACCRUAL Up to 42 patients will be accrued for this study
OUTLINE This is a dose escalation study Patients receive LY231514 IV over 10 minutes followed by irinotecan IV over 90 minutes on day 1 Courses repeat every 3 weeks in the absence of disease progression and unacceptable toxicity Cohorts of 3-6 patients each receive escalating doses of LY231514 and irinotecan If escalation of one drug in the combination results in unacceptable dose limiting toxicity DLT the drug is not escalated further Instead the dose of that drug is decreased to its safe dose and the second drug is escalated until unacceptable DLT results If DLT occurs in 2 of up to 6 patients at any level dose escalation is stopped The maximum tolerated dose is defined as the highest dose at which fewer than 2 of 6 patients experience DLT during courses 1 or 2
PROJECTED ACCRUAL Up to 42 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-V98-1505 | Registry Identifier | PDQ Physician Data Query | None |
| UTHSC-9675011396 | None | None | None |
| CDR0000066819 | REGISTRY | None | None |
| SACI-IDD-97-08 | None | None | None |