Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004860
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2000-03-07
Brief Title:
Fluorouracil-Uracil and Leucovorin in Treating Elderly Patients With Metastatic Colorectal Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Phase II Study of ORZEL UFT Leucovorin in Elderly at Least 75 Years Old Patients With Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2023-06
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 II trial to study the effectiveness of fluorouracil-uracil and leucovorin in treating elderly patients who have metastatic colorectal cancer
PURPOSE Phase II trial to study the effectiveness of fluorouracil-uracil and leucovorin in treating elderly patients who have metastatic colorectal cancer
Detailed Description:
OBJECTIVES I Determine the response rate of elderly patients with metastatic colorectal cancer treated with fluorouracil-uracil and leucovorin calcium Orzel II Evaluate the toxicity profile of this regimen in this patient population III Compare response rates obtained in this study with those observed in recent phase III studies in younger patients
OUTLINE Patients receive oral fluorouracil-uracil and oral leucovorin calcium Orzel every 8 hours for 28 days Courses repeat every 35 days in the absence of unacceptable toxicity or disease progression Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 20-55 patients will be accrued for this study within 1 year
OUTLINE Patients receive oral fluorouracil-uracil and oral leucovorin calcium Orzel every 8 hours for 28 days Courses repeat every 35 days in the absence of unacceptable toxicity or disease progression Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 20-55 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 |
|---|---|---|---|
| E-1299 | None | None | None |