Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00449137
Status:
COMPLETED
Last Update Posted:
2016-12-15
First Post:
2007-03-15
Brief Title:
Arsenic Trioxide Fluorouracil and Leucovorin in Treating Patients With Stage IV Colorectal Cancer That Has Relapsed or Not Responded to Treatment
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
A Phase I Study of 5-FU Plus Leucovorin and Arsenic Trioxide for Patients With RefractoryRelapsed Metastatic Colorectal Carcinoma
Status:
COMPLETED
Status Verified Date:
2016-12
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 such as fluorouracil and leucovorin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Arsenic trioxide may help fluorouracil and leucovorin work better by making tumor cells more sensitive to the drugs Giving arsenic trioxide together with fluorouracil and leucovorin may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of arsenic trioxide and fluorouracil when given together with leucovorin in treating patients with stage IV colorectal cancer that has relapsed or not responded to treatment
PURPOSE This phase I trial is studying the side effects and best dose of arsenic trioxide and fluorouracil when given together with leucovorin in treating patients with stage IV colorectal cancer that has relapsed or not responded to treatment
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and best dose combination of fluorouracil and arsenic trioxide when given together with leucovorin calcium in patients with relapsed or refractory stage IV colorectal cancer
Determine if arsenic trioxide down regulates the expression of thymidylate synthase in tumor and in peripheral blood mononuclear cells in these patients
OUTLINE This is a dose-escalation study of fluorouracil and arsenic trioxide
Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 8 11 15 18 and 22 and fluorouracil IV over 24 hours and leucovorin calcium IV over 24 hours on days 8 15 and 22 Treatment repeats every 5 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 1-6 patients receive escalating doses of fluorouracil and arsenic trioxide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity At least 6 patients are treated at the MTD
Patients undergo peripheral blood mononuclear cell PBMC collection and fine-needle tumor aspiration periodically to determine the effects of arsenic trioxide on thymidylate synthase expression in the tumor and in PBMCs
After completion of study treatment patients are followed periodically for 3 years
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
Determine the maximum tolerated dose and best dose combination of fluorouracil and arsenic trioxide when given together with leucovorin calcium in patients with relapsed or refractory stage IV colorectal cancer
Determine if arsenic trioxide down regulates the expression of thymidylate synthase in tumor and in peripheral blood mononuclear cells in these patients
OUTLINE This is a dose-escalation study of fluorouracil and arsenic trioxide
Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 8 11 15 18 and 22 and fluorouracil IV over 24 hours and leucovorin calcium IV over 24 hours on days 8 15 and 22 Treatment repeats every 5 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 1-6 patients receive escalating doses of fluorouracil and arsenic trioxide until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity At least 6 patients are treated at the MTD
Patients undergo peripheral blood mononuclear cell PBMC collection and fine-needle tumor aspiration periodically to determine the effects of arsenic trioxide on thymidylate synthase expression in the tumor and in PBMCs
After completion of study treatment patients are followed periodically for 3 years
PROJECTED ACCRUAL A total of 20 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 |
|---|---|---|---|
| SCCC-2004162 | None | None | None |