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
EF5
+ flow cytometry
+ fluorescent antibody technique
Urogenital Diseases+47
+ Genital Diseases
+ Breast Diseases
Diagnostic Study
Summary
Study start date: December 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 120 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically proven breast, head and neck, prostate, or cervical carcinoma or high grade (defined as grades 2 or 3) soft tissue sarcoma Sarcoma tumors must be confined to truncal or extremity locations Must have a clinical condition and physiologic status which demonstrates that the appropriate or standard initial therapy for the tumor is surgical biopsy or resection Tumors no greater than 15 cm in any diameter Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Performance status: ECOG 0 or 1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 2,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL Renal: Creatinine less than 2.0 mg/dL OR Creatinine clearance greater than 50 mL/min Cardiovascular: No significant cardiac disease that would preclude the safe use of general anesthesia Pulmonary: No significant pulmonary disease that would preclude the safe use of general anesthesia Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 month after study No grade 3 or 4 peripheral neuropathy PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location