A Comparison of FLT to FDG PET/CT in the Early Assessment of Chemotherapy Response in Stage IB-IIIA Resectable NSCLC

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

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 measuring a response to treatment. A PET scan uses small amounts of radioactive material injected into the blood to show the internal workings of the body. In this study, we will use two radioactive materials: 18F-FLT (referred to as FLT) and 18F-FDG (referred to as FDG). FDG is used routinely in the staging of lung cancer and is approved by the FDA for that purpose. FLT is used in the special type of PET scan being assessed by this study. In addition the study will assess the effects of the combination of docetaxel and cisplatin (chemotherapeutic drugs) on certain pathological characteristics of the tumor. The combination of docetaxel and cisplatin is approved by the Food and Drug Administration (FDA) for the treatment of advanced/metastatic NSCLC (non-small cell lung cancer). It is not approved for use in patients who have surgically removable NSCLC. In such cases cisplatin is used as a single drug therapy before surgery. The FDA is allowing the use of docetaxel along with cisplatin in this research study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Alovudine; BB 1101; Cisplatin; Deoxyglucose; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Dideoxynucleosides; Docetaxel; Fluorodeoxyglucose F18; Succinylcholine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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