Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00231465
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2005-10-03
Brief Title:
Phase II Study of Docetaxel ZD1839 in Elderly Patients With 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 Taxotere Docetaxel ZD1839 IRESSA in Previously Untreated Elderly Patients 70 Years Old With Stage III-b With Malignant Pleural Effusion MPE or Stage IV Non-Small Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2012-08
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 is a Phase II open-label trial of Taxotere ZD1839 in elderly patients with Stage III-b or IV NSCLC who have received no prior chemotherapy for metastatic disease Patients with prior adjuvant chemotherapy were allowed to enroll on this trial
Detailed Description:
This trial is designed to test the efficacy and tolerability of a standard chemotherapy agent Docetaxel in combination with an oral agent Iressa in elderly patients with advanced stage lung cancer Current practices utilize two chemotherapeutic medications that may result in increased toxicities and poor outcomes in the elderly population Treatment consists of an infusion of docetaxel every 21 days for four doses while taking Iressa every day A computed tomography CT scan will measure disease response after two cycles Response determines continuation of treatment Lab work will be collected before every treatment Side effect information will also be collected at every visit Once the infusion phase of the study is completed a maintenance phase of taking just the Iressa begins and disease assessment occurs every two months This period will last until disease progression is demonstrated
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 |
|---|---|---|---|
| 1839US0205 | OTHER | AstraZeneca | None |