Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002828
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
1999-11-01
Brief Title:
Chemotherapy With Raltitrexed and Fluorouracil in Treating Patients With Advanced Colorectal Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
PHASE I TRIAL OF SEQUENTIAL TOMUDEX AND 5-FLUOROURACIL IN SUBJECTS WITH ADVANCED COLORECTAL CARCINOMA
Status:
COMPLETED
Status Verified Date:
2013-06
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 raltitrexed and fluorouracil in treating patients who have colorectal cancer that is metastatic recurrent or cannot be surgically removed
PURPOSE Phase I trial to study the effectiveness of raltitrexed and fluorouracil in treating patients who have colorectal cancer that is metastatic recurrent or cannot be surgically removed
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of raltitrexed when administered with fluorouracil in patients with advanced colorectal carcinoma II Determine the toxicity and safety of this regimen in these patients III Assess in a preliminary manner the antitumor activity of this regimen in these patients
OUTLINE This is a dose-escalation study of raltitrexed Patients receive raltitrexed IV over 15 minutes followed 24 hours later by fluorouracil IV Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of raltitrexed until the maximum tolerated dose MTD is determined The MTD is defined as the dose immediately preceding that at which 2 of 6 patients experience dose-limiting toxicity An additional 6-10 patients are treated at the MTD Patients are followed for 6 weeks
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 5-20 months
OUTLINE This is a dose-escalation study of raltitrexed Patients receive raltitrexed IV over 15 minutes followed 24 hours later by fluorouracil IV Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of raltitrexed until the maximum tolerated dose MTD is determined The MTD is defined as the dose immediately preceding that at which 2 of 6 patients experience dose-limiting toxicity An additional 6-10 patients are treated at the MTD Patients are followed for 6 weeks
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 5-20 months
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-V96-0987 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000065019 | REGISTRY | None | None |
| ZENECA-MSKCC-95021A4 | None | None | None |