Clinical trial · Interventional
EF5 in Assessing Tumor Response to Anticancer Therapy in Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
Pilot Phase II Research Study of EF5 to Measure Tumor Hypoxia in Patients With Non-Small Cell Lung Cancer
NCT00041028CI-TRIAL-00017762completedPhase 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)
RATIONALE: Knowing the level of oxygen in tumor tissue may help predict the effectiveness of anticancer therapy. EF5 is a drug used in the measurement of oxygen in tumor tissue. PURPOSE: Phase II trial to study the effectiveness of EF5 in assessing tumor response to anticancer therapy in patients who have stage I, stage II, or stage III non-small cell lung cancer.
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EF5 | Drug | — | UNRESOLVED |
| flow cytometry | Other | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Frequency and degree of hypoxia as measured by EF5 binding at 24 to 48 hrs. after study drug infusion
Secondary outcomes (2)
- measure
- Correlation of hypoxia with serum/plasma markers of hypoxia, tissue markers of hypoxia, tumor angiogenesis, apoptosis, tumor perfusion, and microvessel density at 24 to 48 hrs. after study drug infusion
- measure
- Longevity of EF5 adducts as measured by EF5 binding
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed or suspected non-small cell lung cancer (NSCLC)
* If there is no histological or cytological documentation of NSCLC, must have at least a 75% probability of having NSCLC
* Clinical or pathological stage I-III
* Patients in whom pre-surgical staging has not definitively established stage IV disease are allowed
* Tumor mass of ≥ 1.5 cm in maximum diameter must be present on CT scan and must be included in the planned surgical biopsy or resection
* Must be planning to undergo a surgical staging or treatment procedure (including mediastinoscopy, wedge resection, lobectomy, or pneumonectomy)
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* 0-2
Life expectancy:
* Not specified
Hematopoietic:
* WBC \> 2,000/mm\^3
* Platelet count \> 100,000/mm\^3
Hepatic:
* Bilirubin normal
Renal:
* Creatinine normal OR
* Creatinine clearance ≥ 60 mL/min
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 1 month after study participation
* Able to hold breath for 27 seconds
* No allergy to IV contrast dye
* No history of grade III or IV peripheral neuropathy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* See Disease CharacteristicsReferences
Publications (0)
Data not yet available
No reference posted for this study.