Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00226577
Status:
COMPLETED
Last Update Posted:
2017-03-23
First Post:
2005-09-23
Brief Title:
Pharmacogenomic Phase II Study of Gemcitabine and Pemetrexed in Non-Small-Cell Lung Cancer
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Phase II Study of Neoadjuvant Chemotherapy With Gemcitabine and Pemetrexed in Resectable Non-Small-Cell Lung Cancer NSCLC With Pharmacogenomic Correlates
Status:
COMPLETED
Status Verified Date:
2011-01
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:
This study will evaluate the efficacy and safety of chemotherapy given prior to having lung cancer surgically removed Patients with resectable non-small cell lung cancer will receive gemcitabine and pemetrexed together for 4 times biweekly Patients will be seen by a medical oncologist prior to each cycle of chemotherapy given The medical oncologist will review patients bloodwork and symptoms prior to approving next cycle of chemotherapy All patients will then be evaluated with scans to determine response to chemotherapy and to determine if patient is a surgical candidate These patients will then proceed to surgery to have the lung cancer removed Follow up visits include bloodwork scans and a visit with the medical oncologist every three months for two years then every six months for three years to monitor for disease recurrence
Detailed Description:
This study will evaluate the efficacy and safety of neoadjuvant chemotherapy with gemcitabine and pemetrexed given together 4-times biweekly in patients with resectable NSCLC All patients will be seen by members of the Thoracic Oncology Program at the H Lee Moffitt Cancer Center and Research Institute in Tampa Florida and they will be discussed in our weekly multidisciplinary thoracic oncology conference The conference includes pathologists radiologists thoracic surgeons pulmonologists radiation oncologists medical oncologists oncology nurse specialists case managers social workers and clinical trials coordinators They will have initial tests as outlined in the study timetable Patients will receive gemcitabine biweekly on days 1 15 29 and 43 at a dose of 1500 mgm2 They will also receive pemetrexed at a dose of 500 mgm2 on days 1 15 29 and 43 Gemcitabine will be given first over a period of 30 minutes iv followed by pemetrexed over 10 minutes iv All patients will get a post induction chemotherapy PET scan CT scan and PFTs including a DLCO They will then go on to thoracotomy including bronchoscopy and mediastinal lymph node dissection between days 64 and 77 if the tumor is deemed completely resectable on restaging studies
The administration of chemotherapy at the earliest time neoadjuvant or induction chemotherapy following diagnosis in an effort to reduce the risk of disease recurrence This approach also allows for investigations of molecular parameters that may affect response to chemotherapy and patients survival It is our hypothesis that the expression of genes associated with activation inactivation and efficacy of the drugs gemcitabine and pemetrexed will predict response to therapy and prognosis We further hypothesize that the expression of these genes will be altered during chemotherapy and that the global assessment of tumor proliferation apoptosis and genome damage is associated with response to therapy We propose a phase II study of neoadjuvant chemotherapy with gemcitabine and pemetrexed in patients with resectable NSCLC specifically correlating molecular and genetic parameters to the primary clinical study endpoint disease response radiographic CRPR and the secondary endpoints complete pathological response at surgery disease-free survival and overall survival
The administration of chemotherapy at the earliest time neoadjuvant or induction chemotherapy following diagnosis in an effort to reduce the risk of disease recurrence This approach also allows for investigations of molecular parameters that may affect response to chemotherapy and patients survival It is our hypothesis that the expression of genes associated with activation inactivation and efficacy of the drugs gemcitabine and pemetrexed will predict response to therapy and prognosis We further hypothesize that the expression of these genes will be altered during chemotherapy and that the global assessment of tumor proliferation apoptosis and genome damage is associated with response to therapy We propose a phase II study of neoadjuvant chemotherapy with gemcitabine and pemetrexed in patients with resectable NSCLC specifically correlating molecular and genetic parameters to the primary clinical study endpoint disease response radiographic CRPR and the secondary endpoints complete pathological response at surgery disease-free survival and overall survival
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 |
|---|---|---|---|
| H3E-US-X009 | OTHER | Eli Lilly Company | None |