Early Positron Emission Tomography as a Predictor of Response in Neoadjuvant Chemotherapy for Non-Small Cell Lung Cancer
Overview
- Phase
- Phase 2
- Intervention
- pemetrexed disodium
- Conditions
- Lung Cancer
- Sponsor
- University of Washington
- Enrollment
- 25
- Locations
- 2
- Primary Endpoint
- Positron Emission Tomography as a Predictor of Response Measured by the Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Renato Martins
Principal Investigator
University of Washington
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Neoadjuvant therapy, PET scan and surgery
Intervention: pemetrexed disodium
Neoadjuvant therapy, PET scan and surgery
Intervention: adjuvant therapy
Neoadjuvant therapy, PET scan and surgery
Intervention: cisplatin
Neoadjuvant therapy, PET scan and surgery
Intervention: therapeutic conventional surgery
Neoadjuvant therapy, PET scan and surgery
Intervention: fludeoxyglucose F 18
Outcomes
Primary Outcomes
Positron Emission Tomography as a Predictor of Response Measured by the Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy
Time Frame: Between days 18 and 22 prior to second chemotherapy infusion
Number of Participants with Decrease in Standard Uptake Variable (SUV) After 1 Course of Therapy
Secondary Outcomes
- Safety of Neoadjuvant Chemotherapy(Up to 4 weeks after last dose of chemotherapy)
- Efficacy of Neoadjuvant Chemotherapy as Measured by Radiologic Response Rate(Up to 4 weeks after last dose of chemotherapy)