Clinical trial · Interventional
EF5 in Treating Patients With Solid Tumors
Phase I Trial of EF5, an Agent for the Detection of Hypoxia
NCT00003282CI-TRIAL-00008958completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Diagnostic procedures using the drug EF5 to detect the presence of oxygen in tumor cells may help to plan effective treatment for solid tumors. This phase I trial is studying how well EF5 works in detecting the presence of oxygen in tumor cells in patients with solid tumors that can be biopsied or removed by surgery
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Procedure | — | UNRESOLVED |
| EF5 | Drug | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (EF5)
- description
- Patients receive etanidazole derivative EF5 IV over 1-2 hours beginning approximately 24 hours prior to surgery. Tumors are then resected or biopsied after Eppendorf needle electrode measurements.
- interventionNames
- Drug: EF5
- Procedure: therapeutic conventional surgery
- Procedure: biopsy
- Other: pharmacological study
Primary outcomes (6)
- measure
- Pharmacokinetics parameters including estimation of Cmax, half-life, and area under the time-concentration curve (AUC)
- timeFrame
- Pre-dose, 1, 24, and 28 hours
- measure
- Acute toxicity graded by NCI/DCTDC Common Toxicity Criteria
- timeFrame
- Up to 24 hours
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed tumor or highly suspicious cancerous mass based on imaging and clinical signs but not indicative of a direct biopsy/cellular diagnosis preceding surgery * Must have a clinical condition or physiologic status which demonstrates that the appropriate or standard initial therapy for the tumor is surgical biopsy or resection * Performance status - ECOG 0-2 * Life expectancy not specified * WBC greater than 2,000/mm\^3 * Platelet count greater than 100,000/mm\^3 * Bilirubin less than 2.0 mg/dL * Creatinine less than 2.0 mg/dL * Creatinine clearance greater than 50 mL/min * No significant cardiac disease that would preclude the safe use of general anesthesia * No significant pulmonary disease that would preclude the safe use of general anesthesia * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 1 month after study * No history of grade III or IV peripheral neuropathy * See Disease Characteristics
References
Publications (0)
Data not yet available
No reference posted for this study.