Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma

Basic Trial Information

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.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 Not specified

Endocrine therapy:
 Not specified

Radiotherapy:
 Not specified

Surgery:
 See Disease Characteristics

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

Expected Enrollment

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.  

Trial Contact Information

Trial Lead Organizations

Ontario Cancer Institute at Princess Margaret Hospital

Anthony Fyles, MD, Protocol chair (Contact information may not be current)		Ph: 416-924-0671

Registry Information
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
Trial Start Date		1999-12-01
Registered in ClinicalTrials.gov		NCT00004261
Date Submitted to PDQ		2000-01-04
Information Last Verified		2002-06-01

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