EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma
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.
|Breast Cancer Cervical Cancer Head and Neck Cancer Prostate Cancer Sarcoma||Drug: EF5 Other: flow cytometry Other: fluorescent antibody technique Other: immunohistochemistry staining method Procedure: biopsy||Phase 1|
|Study Design:||Primary Purpose: Diagnostic|
|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|
|Study Start Date:||December 1999|
|Estimated Primary Completion Date:||June 2002 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004261
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Study Chair:||Anthony Fyles, MD||Princess Margaret Hospital, Canada|