Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00227539
Status:
COMPLETED
Last Update Posted:
2017-05-09
First Post:
2005-09-26
Brief Title:
Positron Emission Tomography 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
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Early Positron Emission Tomography as a Predictor of Response in Neoadjuvant Chemotherapy for Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Diagnostic procedures such as positron emission tomography PET done before during and after chemotherapy may help doctors predict a patients 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000441239 | REGISTRY | PDQ | httpsreporternihgovquickSearchP30CA015704 |
| P30CA015704 | NIH | None | None |
| UWCC-6228 | None | None | None |
| UWCC-UW-6228 | None | None | None |
| UW-04033 | None | None | None |
| LILY-UW-04033 | None | None | None |