Lung Cancer Clinical Trial
Official title:
Early Positron Emission Tomography as a Predictor of Response in Neoadjuvant Chemotherapy for Non-Small Cell Lung Cancer
RATIONALE: Diagnostic procedures, such as positron emission tomography (PET), (done before,
during, and after chemotherapy) may help doctors predict a patient's response to treatment
and help plan the best treatment. Drugs used in chemotherapy, such as pemetrexed disodium
and cisplatin, work in different ways to stop the growth of tumor cells, either by killing
the cells or by stopping them from dividing. Giving combination chemotherapy after surgery
may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well PET works in predicting response in
patients who are undergoing treatment with pemetrexed disodium and cisplatin with or without
surgery for stage I, stage II, or stage III non-small cell lung cancer.
OBJECTIVES:
Primary
- Determine the effectiveness of fludeoxyglucose F 18 positron emission tomography in
predicting radiological and pathological response in patients treated with pemetrexed
disodium and cisplatin with or without surgery for stage IB-IIIB non-small cell lung
cancer (NSCLC).
Secondary
- Determine the safety of cisplatin and pemetrexed disodium in these patients.
- Determine the radiographic response rate, duration of response, and time to progression
in patients treated with cisplatin and pemetrexed disodium.
OUTLINE: This is a multicenter study.
- Fludeoxyglucose F 18 (18FDG) positron emission tomography (PET) imaging: All patients
undergo positron emission tomography (PET) imaging of the head, neck, thorax, abdomen,
and pelvis. Patients receive fludeoxyglucose F 18 (^18FDG) IV followed by 45 minutes of
rest. PET imaging is done over 1 hour and 8 minutes. Patients undergo PET imaging at
three points during the study: 4 weeks prior to treatment, after the first cycle of
treatment, and after 3 courses of chemotherapy. Some patients then undergo surgical
resection of the tumor.
- Chemotherapy: Patients receive cisplatin IV over 30 minutes and pemetrexed disodium IV
over 10 minutes on day 1. Courses repeat every 21 days for up to 3 courses in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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