Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003109
Status:
COMPLETED
Last Update Posted:
2013-04-17
First Post:
1999-11-01
Brief Title:
Irinotecan Plus Raltitrexed in Treating Patients With Refractory Solid Tumors
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
Phase I Pharmacokinetic and Pharmacodynamic Trial of Irinotecan in Combination With Tomudex in Patients With Refractory Solid Malignancies
Status:
COMPLETED
Status Verified Date:
2013-04
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 irinotecan plus raltitrexed in treating patients who have refractory solid tumors that have not responded to previous therapy
PURPOSE Phase I trial to study the effectiveness of irinotecan plus raltitrexed in treating patients who have refractory solid tumors that have not responded to previous therapy
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of irinotecan in combination with raltitrexed in patients with refractory solid tumors II Describe and quantify the toxic effects of this combination treatment regimen in a minimally pretreated patient population III Determine the pharmacokinetics of this combination treatment regimen IV Document any antitumor activity of this combination treatment regimen in this patient population
OUTLINE This is a dose escalation study of irinotecan and raltitrexed Patients receive irinotecan IV over 90 minutes on days 1 and 8 followed by raltitrexed IV over 15 minutes on day 1 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients each receive escalating doses of irinotecan and raltitrexed until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities Additional cohorts receive raltitrexed on day 2 rather than day 1 near the final dose levels of the combination drugs
PROJECTED ACCRUAL A maximum of 36 patients will be accrued for this study within 1 year
OUTLINE This is a dose escalation study of irinotecan and raltitrexed Patients receive irinotecan IV over 90 minutes on days 1 and 8 followed by raltitrexed IV over 15 minutes on day 1 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients each receive escalating doses of irinotecan and raltitrexed until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities Additional cohorts receive raltitrexed on day 2 rather than day 1 near the final dose levels of the combination drugs
PROJECTED ACCRUAL A maximum of 36 patients will be accrued for this study within 1 year
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-T96-0113 | OTHER | National Cancer Institute | httpsreporternihgovquickSearchP30CA006927 |
| P30CA006927 | NIH | None | None |
| FCCC-96116 | OTHER | None | None |