CompletedPhase 2NCT00041028

EF5 in Assessing Tumor Response to Anticancer Therapy in Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer

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.

Checked against the public recordLast updated May 1, 2015 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations2
SponsorDuke University
01
Study overview

What this study is about

Purpose
Diagnostic
Study type
Interventional
Phase
Phase 2
Sponsor
Duke University
Interventions being studied
Drug: EF5; Other: flow cytometry; Other: immunohistochemistry staining method
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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 Characteristics

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Duke Comprehensive Cancer CenterDurham, North Carolina
  • Veterans Affairs Medical Center - DurhamDurham, North Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 1, 2015. Always confirm current availability with the study team.

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