Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003709
Status:
COMPLETED
Last Update Posted:
2012-08-09
First Post:
1999-11-01
Brief Title:
Chemotherapy in Treating Patients With Advanced Solid Tumors
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
Phase I and Pharmacokinetic Study of FB-642 Administered Orally on a Weekly Schedule to Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2012-08
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
PURPOSE Phase I trial to study the effectiveness of carbendazim in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of carbendazim in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of oral carbendazim in patients with advanced solid tumors II Determine the qualitative and quantitative toxic effects of oral carbendazim in these patients III Characterize the pharmacokinetic profile of oral carbendazim in these patients IV Assess the recommended dose of oral carbendazim to be used in phase II studies V Determine preliminary evidence of antitumor activity of this regimen in these patients
OUTLINE This is a dose escalation study Patients receive oral carbendazim weekly for 3 weeks followed by 1 week of rest Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxic effects Cohorts of 3-6 patients receive escalating doses of carbendazim If dose limiting toxicity DLT is seen in 1 of 3 patients treated at a given dose level 3 additional patients will be entered at the same dose level Dose escalation continues until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience DLT Patients are followed for up to 30 days posttreatment
PROJECTED ACCRUAL Up to 35 patients will be accrued for this study
OUTLINE This is a dose escalation study Patients receive oral carbendazim weekly for 3 weeks followed by 1 week of rest Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxic effects Cohorts of 3-6 patients receive escalating doses of carbendazim If dose limiting toxicity DLT is seen in 1 of 3 patients treated at a given dose level 3 additional patients will be entered at the same dose level Dose escalation continues until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience DLT Patients are followed for up to 30 days posttreatment
PROJECTED ACCRUAL Up to 35 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 |
|---|---|---|---|
| P30CA054174 | NIH | None | None |
| UTHSC-9895011080 | OTHER | None | None |
| ILEX-FB-642-101 | OTHER | None | None |
| SACI-IDD-98-21 | OTHER | None | None |
| NCI-V98-1503 | OTHER | NCI | httpsreporternihgovquickSearchP30CA054174 |