Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002796
Status:
TERMINATED
Last Update Posted:
2013-02-01
First Post:
1999-11-01
Brief Title:
Phase I-II Study of Fluorouracil in Combination With Phenylbutyrate in Advanced Colorectal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I-II Study of Fluorouracil in Combination With Phenylbutyrate Indomethacin and Recombinant Human Interferon-Gamma in Advanced Colorectal Cancer
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively complete
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Interferon-gamma may interfere with the growth of tumor cells and slow the growth of the tumor Combining more than one drug with interferon-gamma may kill more tumor cells This phase III trial is studying the side effects and best dose of giving fluorouracil together with phenylbutyrate indomethacin and interferon-gamma and to see how well it works in treating patients with stage IV colorectal cancer
Detailed Description:
PRIMARY OBJECTIVES
I To determine in a Phase I study the toxicity of flurouracil FU when given in escalating doses in combination with fixed doses of phenlylbutyrate PB indomethacin and recombinant human interferon-gamma rhIFNg to patients with advanced colorectal cancer
II To determine in a Phase II study the efficacy of FU in combination with PB indomethacin and rhIFNg in patients with advanced colorectal cancer
OUTLINE This is a dose-escalation study of fluorouracil 5-FU
Phase I Patients receive 5-FU IV over 24 hours on day 1 phenylbutyrate IV over 120 hours and oral indomethacin daily on days 2-6 and interferon gamma subcutaneously on days 2 4 and 6 Courses repeat weekly in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of 5-FU until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which less than 2 of 6 patients experience dose-limiting toxicity DLT
Phase II Patients receive 5-FU phenylbutyrate indomethacin and interferon gamma as in phase I at the MTD
Patients are followed for survival
PROJECTED ACCRUAL A maximum of 24 patients will be accrued for the phase I portion of this study and approximately 46 patients will be accrued for the phase II portion of this study
I To determine in a Phase I study the toxicity of flurouracil FU when given in escalating doses in combination with fixed doses of phenlylbutyrate PB indomethacin and recombinant human interferon-gamma rhIFNg to patients with advanced colorectal cancer
II To determine in a Phase II study the efficacy of FU in combination with PB indomethacin and rhIFNg in patients with advanced colorectal cancer
OUTLINE This is a dose-escalation study of fluorouracil 5-FU
Phase I Patients receive 5-FU IV over 24 hours on day 1 phenylbutyrate IV over 120 hours and oral indomethacin daily on days 2-6 and interferon gamma subcutaneously on days 2 4 and 6 Courses repeat weekly in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of 5-FU until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which less than 2 of 6 patients experience dose-limiting toxicity DLT
Phase II Patients receive 5-FU phenylbutyrate indomethacin and interferon gamma as in phase I at the MTD
Patients are followed for survival
PROJECTED ACCRUAL A maximum of 24 patients will be accrued for the phase I portion of this study and approximately 46 patients will be accrued for the phase II portion of 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 |
|---|---|---|---|
| CDR0000064879 | REGISTRY | PDQ Physician Data Query | None |
| 96-322 ME | None | None | None |