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.

Condition	Treatment or Intervention	Phase
Salivary Gland Cancer lip and oral cavity cancer adult soft tissue sarcoma Head and Neck Cancer Prostate Cancer Cervical Cancer Oropharyngeal Cancer Breast Cancer	Procedure: diagnostic  Drug: EF5	Phase I

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL 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

Canada, Ontario
      Princess Margaret Hospital, Toronto,  Ontario,  M5G 2M9,  Canada

Study chairs or principal investigators

Anthony Fyles,  Study Chair,  Ontario Cancer Institute   

Study ID Numbers:  CDR0000067516; CAN-OCI-T98-0048; NCI-T98-0048
Record last reviewed:  December 2003
Last Updated:  October 13, 2004
Record first received:  January 28, 2000
ClinicalTrials.gov Identifier:  NCT00004261
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08