Breast Cancer Clinical Trial
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
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.
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.
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