Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004261
Status:
TERMINATED
Last Update Posted:
2018-02-22
First Post:
2000-01-28
Brief Title:
EF5 Prior to Surgery or Biopsy in Patients With Breast Prostate or Cervical Cancer or High Grade Soft Tissue Sarcoma
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Phase I Trial of the Hypoxia Detection Agent EF5 NSC 684681 in Patients With Cervix and Breast and Prostate Carcinomas and High Grade Soft Tissue Sarcomas
Status:
TERMINATED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of patient accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE EF5 may detect the presence of oxygen in tumor cells and help plan effective cancer treatment
PURPOSE Phase I trial to study the effectiveness of EF5 in detecting the presence of oxygen in tumor cells of patients who are undergoing surgery or biopsy for breast prostate or cervical cancer or high grade soft tissue sarcoma
PURPOSE Phase I trial to study the effectiveness of EF5 in detecting the presence of oxygen in tumor cells of patients who are undergoing surgery or biopsy for breast prostate or cervical cancer or high grade soft tissue sarcoma
Detailed Description:
OBJECTIVES I Determine the optimal dose of etanidazole derivative EF5 that is safely tolerated and provides optimal binding in resected tumor specimens or tumor biopsies in patients with breast head and neck prostate or cervical carcinoma or high grade soft tissue sarcomas II Define the toxic effects of EF5 in this patient population
OUTLINE This is a dose-escalation study Patients receive etanidazole derivative EF5 IV over 1-2 hours Approximately 24-48 hours after EF5 treatment patients undergo surgical resection or biopsy of tumor Cohorts of 6 patients receive escalating doses of EF5 until the maximum tolerated dose MTD or optimal dose is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity The optimal dose is defined as the dose level at or preceding the MTD and resulting in optimal tumor-to-normal-tissue binding Patients are followed at 28 days
PROJECTED ACCRUAL A total of 18-36 patients will be accrued for this study within 12-18 months
OUTLINE This is a dose-escalation study Patients receive etanidazole derivative EF5 IV over 1-2 hours Approximately 24-48 hours after EF5 treatment patients undergo surgical resection or biopsy of tumor Cohorts of 6 patients receive escalating doses of EF5 until the maximum tolerated dose MTD or optimal dose is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity The optimal dose is defined as the dose level at or preceding the MTD and resulting in optimal tumor-to-normal-tissue binding Patients are followed at 28 days
PROJECTED ACCRUAL A total of 18-36 patients will be accrued for this study within 12-18 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-T98-0048 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067516 | REGISTRY | None | None |