Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003446
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
1999-11-01
Brief Title:
Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer
Sponsor:
Grupo Oncologico Cooperativo del Sur
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of Trimetrexate Neutrexin 5-Fluorouracil and Leucovorin in Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2001-09
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 II trial to study the effectiveness of trimetrexate glucuronate fluorouracil and leucovorin in treating patients with recurrent or metastatic colorectal cancer
PURPOSE Phase II trial to study the effectiveness of trimetrexate glucuronate fluorouracil and leucovorin in treating patients with recurrent or metastatic colorectal cancer
Detailed Description:
OBJECTIVES I Evaluate tumor response and duration one-year progression-free survival and one-year overall survival in patients with recurrent or metastatic colorectal carcinoma when treated with trimetrexate glucuronate fluorouracil and leucovorin calcium
OUTLINE Patients receive trimetrexate glucuronate TMTX IV over 1 hour on day 1 Beginning 18 hours after the TMTX dosage patients receive leucovorin calcium CF IV over 2 hours Immediately after the completion of the CF infusion patients receive an IV bolus injection of fluorouracil 5-FU Beginning 4 hours after the 5-FU infusion patients receive oral CF every 6 hours for 6 doses Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity or as long as the disease remains inoperable Patients are followed every 3 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 18-45 patients will be accrued for this study within 15 months
OUTLINE Patients receive trimetrexate glucuronate TMTX IV over 1 hour on day 1 Beginning 18 hours after the TMTX dosage patients receive leucovorin calcium CF IV over 2 hours Immediately after the completion of the CF infusion patients receive an IV bolus injection of fluorouracil 5-FU Beginning 4 hours after the 5-FU infusion patients receive oral CF every 6 hours for 6 doses Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity or as long as the disease remains inoperable Patients are followed every 3 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 18-45 patients will be accrued for this study within 15 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-V98-1457 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066475 | REGISTRY | None | None |