Clinical trial · Interventional
EF5 in Finding Oxygen in Tumor Cells of Patients Who Are Undergoing Surgery or Biopsy for Cervical, Endometrial, or Ovarian Epithelial Cancer
Evaluation of Hypoxia by EF5 Binding in Gynecologic Cancer
NCT00107445CI-TRIAL-00008918completedPhase 2ClinicalTrials.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)
This phase II trial is studying how well EF5 works in finding oxygen in tumor cells of patients who are undergoing surgery or biopsy for cervical, endometrial, or ovarian epithelial cancer. Diagnostic procedures using the drug EF5 to find oxygen in tumor cells may help in planning cancer treatment
Conditions
Conditions (16)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Peritoneal Cavity Cancer | — | UNRESOLVED | — |
| Stage IA Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Endometrial Carcinoma | Endometrial Carcinoma | CURATED_BROADER | 0.78 |
| Stage IIA Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Endometrial Carcinoma | Endometrial Carcinoma | CURATED_BROADER | 0.78 |
| Stage III Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Endometrial Carcinoma | Endometrial Carcinoma |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EF5 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (EF5)
- description
- Patients receive EF5 IV over 1-2½ hours on day 1. Approximately 1-2 days later, patients undergo tumor resection or biopsy. Patients' tumor tissue samples undergo immunohistochemistry and flow cytometry to detect EF5 binding levels. Patients' blood is drawn immediately before and 30-60 minutes and 1-2 days after receiving EF5 to measure systemic EF5 binding levels.
- interventionNames
- Drug: EF5
Primary outcomes (4)
- measure
- Level of EF5 binding
- timeFrame
- Baseline
- description
- The relationship between the level of EF5 binding and hemoglobin will be summarized by Pearson's correlation coefficient.
- measure
- Hemoglobin level
- timeFrame
- Baseline
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed\* diagnosis of 1 of the following: * Cervical cancer * Ovarian epithelial cancer * Endometrial cancer * Peritoneal cavity cancer * Requires surgery or biopsy for diagnosis or as standard initial treatment for the tumor * Performance status - ECOG 0-2 * WBC ≥ 2,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Bilirubin normal * Creatinine normal * Creatinine clearance ≥ 60 mL/min * No significant cardiac condition that would preclude study participation * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 1 month after study participation * Weight ≤ 130 kg * No other significant medical condition that would preclude study participation * No scheduled chemotherapy for the tumor within the past 3 months * No scheduled radiotherapy to the tumor within the past 3 months * No other concurrent investigational agents
References
Publications (0)
Data not yet available
No reference posted for this study.