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

NCT00041028 | Completed Phase 2

• 4 other identifiers: Pro00011318DUMC-0041-M1RB00622NCI-2310CDR0000069437
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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

Lung Cancer

Keywords

stage I non-small cell lung cancer; stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Frequency and degree of hypoxia as measured by EF5 binding at 24 to 48 hrs. after study drug infusion

Secondary Outcomes (2)

• 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

• Longevity of EF5 adducts as measured by EF5 binding

Interventions

EF5 DRUG

flow cytometry OTHER

immunohistochemistry staining method OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Duke University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Duke Comprehensive Cancer Center

Durham, North Carolina, 27705, United States

Location

Veterans Affairs Medical Center - Durham

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Flow Cytometry; Immunohistochemistry

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Histocytochemistry; Histological Techniques; Immunologic Techniques

Study Officials

• Michael J. Kelley, MD

  Duke Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: DIAGNOSTIC
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 8, 2002
• First Posted: January 27, 2003
• Study Start: May 1, 2002
• Primary Completion: September 1, 2007
• Study Completion: April 1, 2014
• Last Updated: May 1, 2015

Record last verified: 2006-09

Locations

US (2)