Status:
COMPLETED
A Comparison of FLT to FDG PET/CT in the Early Assessment of Chemotherapy Response in Stage IB-IIIA Resectable NSCLC
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Non-Small Cell Lung Carcinoma
Stage IB Non-Small Cell Lung Carcinoma
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
This study is being done to compare a special type of Positron Emission Tomography (PET) scan with CT scan in patients with surgically removable lung cancer to see which method is more useful in measu...
Detailed Description
PRIMARY OBJECTIVES: I. To determine if the absolute decrease measured in primary tumor 18 F-F-3'-fluoro-3'-deoxy-L-thymidine (FLT) uptake (standard uptake value \[SUV\] and influx constant \[Ki\]) be...
Eligibility Criteria
Inclusion
- Patients must have histologically or cytologically confirmed clinical stage IB - IIIA non-small cell lung cancer; stage IV patients with oligometastatic disease with metastases that have been treated definitively with radiation or surgery are also eligible (ie: solitary brain or adrenal metastasis); mixed tumors will be categorized by the predominant cell type unless small cell elements are present in which case the patient is ineligible; note: tissue samples from biopsy confirmation will be required
- Patients must be surgically resectable as determined by a thoracic surgeon
- Patients must have measurable disease per RECIST 1.1, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 10 mm with spiral CT scan
- Life expectancy of greater than 12 weeks
- ECOG performance status \< 1
- Leukocytes \>= 3,000/uL
- Absolute neutrophil count \>= 1,500/uL
- Platelets \>= 100,000/uL
- Total bilirubin =\< 1.5 x institutional upper limit of normal
- AST (SGOT) =\< 1.5 x institutional upper limit of normal
- Alkaline phosphatase =\< 2.5 x institutional upper limit of normal
- Creatinine =\< 1.5 x institutional upper limit of normal OR creatinine clearance \>= 60 mL/1.73 m2 for patients with creatinine levels above institutional normal
- Fasting screening blood glucose =\< 200 mg/dL
- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with either agent
Exclusion
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Patients may not be receiving any other investigational agents
- Patients must not have received prior systemic chemotherapy or radiation therapy for lung cancer; prior systemic chemotherapy or radiation for other malignancies over three years prior to study enrollment may be allowed at the discretion of the principal medical investigator
- Prior malignancy in the past 3 years, other than non-melanoma skin cancer and in situ carcinoma of the cervix
- Patients who report a hearing deficit at baseline, even if it does not require a hearing aid or intervention, or interfere with activities of daily life (Common Terminology Criteria for Adverse Events \[CTCAE\] grade 2 or higher)
- Peripheral neuropathy \> CTCAE grade 1
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to cisplatin, docetaxel, or other agents used in the study
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled diabetes, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric/social situations that would limit compliance with study requirements
- HIV-positive patients on combination antiretroviral therapy are ineligible
- Inability to comply with study and/or follow-up procedures
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00963807
Start Date
September 1 2009
End Date
November 1 2014
Last Update
March 17 2017
Active Locations (2)
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1
Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
2
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210