Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125359
Status:
COMPLETED
Last Update Posted:
2019-01-08
First Post:
2005-07-29
Brief Title:
Study of Tarceva and Targretin Oral Capsules in Patients With Advanced Lung Cancer
Sponsor:
Konstantin Dragnev
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
A Phase II Clinical Study of Erlotinib Tarceva and Bexarotene Targretin Oral Capsules in Patients With Advanced Non-small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2018-12
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:
The purpose of this study is to learn about the effects of two new anticancer drugs erlotinib Tarceva and bexarotene Targretin when treating patients with advanced lung cancer
Erlotinib is approved by the Food and Drug Administration FDA for the treatment of non-small-cell lung cancer NSCLC Bexarotene is approved by the FDA for the treatment of cutaneous T-cell lymphoma This combination of drugs is experimental
Erlotinib is approved by the Food and Drug Administration FDA for the treatment of non-small-cell lung cancer NSCLC Bexarotene is approved by the FDA for the treatment of cutaneous T-cell lymphoma This combination of drugs is experimental
Detailed Description:
This is a single institution open label phase II trial Consecutive eligible patients presenting with the diagnosis of advanced NSCLC are to be enrolled in this study All eligible patients will receive continuous daily oral erlotinib 150 mg Tarceva with daily bexarotene oral capsules 400 mgm2 Targretin The two agents will be taken at the same time We anticipate the maximum accrual of 40 patients to this trial
Patients will be evaluated by history physical examination and laboratory assessment every 4 weeks Radiographic disease assessments by chest radiograph will be obtained every 4 weeks and computer tomography every 8 weeks or longer if clinically indicated Whole body PET scan will be obtained at 10 days and 8 weeks All radiographic studies will be sent to Medical Metrix Solutions MMS for an independent radiographic review of tumor response
Patients will be evaluated by history physical examination and laboratory assessment every 4 weeks Radiographic disease assessments by chest radiograph will be obtained every 4 weeks and computer tomography every 8 weeks or longer if clinically indicated Whole body PET scan will be obtained at 10 days and 8 weeks All radiographic studies will be sent to Medical Metrix Solutions MMS for an independent radiographic review of tumor response
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