Phase 2
Completed N=26
A Comparison of FLT to FDG PET/CT in the Early Assessment of Chemotherapy Response in Stage IB-IIIA Resectable NSCLC
Recurrent Non-Small Cell Lung Carcinoma · Stage IB Non-Small Cell Lung Carcinoma · Stage IIA Non-Small Cell Lung Carcinoma · Stage IIB Non-Small Cell Lung Carcinoma
Source: ClinicalTrials.gov NCT00963807 ↗
Enrolled (actual)
26
Serious AEs
44.4%
Results posted
Mar 2017
Primary outcomePrimary: Change in 18F-Fluorothymidine (FLT) Uptake — -0.4 SULmax
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in 18F-Fluorothymidine (FLT) Uptake |
-0.4 | — |
| PRIMARY Change in FLT Uptake |
0.2 | — |
| PRIMARY Change in FLT Uptake in Responders and Non-responders |
-1.8; 1.2 | 0.336 |
| SECONDARY Change in 18F-Fluorodeoxyglucose (FDG) Uptake |
-3.8 | — |
| SECONDARY Overall Response Rate Reported as a Proportion of the Total Number of Patients Who Received at Least One Cycle of Therapy Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) |
33 | — |
Eligibility 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 = 3,000/uL
- Absolute neutrophil count >= 1,500/uL
- Platelets >= 100,000/uL
- Total bilirubin = = 60 mL/1.73 m2 for patients with creatinine levels above institutional normal
- Fasting screening blood glucose = 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
Data sourced from ClinicalTrials.gov (NCT00963807). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.