Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00153842
Status:
TERMINATED
Last Update Posted:
2019-03-06
First Post:
2005-09-08
Brief Title:
A Study of Paclitaxel and Carboplatin in Combination With Bexarotene Oral Capsules in Patients With Advanced Lung Cancer
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
Phase I and II Clinical Studies of Paclitaxel and Carboplatin in Combination With Bexarotene Oral Capsules for the Treatment of Patients With Advanced Non-Small Cell Lung Cancer
Status:
TERMINATED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
other trials show no survival benefit of bexarotene with platinum-based chemo
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary aim is to evaluate the safety Phase I components of administering bexarotene Targretin LGD1069 oral capsules in combination with two Taxol and carboplatin Paraplatin schedules to patients with stage IIIB and IV non-small cell lung cancer This study will also evaluate the preliminary efficacy Phase II component of bexarotene oral capsules in combination with the weekly Taxol schedule and carboplatin in these patients
Detailed Description:
The phase I portion of the study will evaluate the safety of administering bexarotene oral capsules daily at two dose levels 300 mgm2 and 400 mgm2 in combination with carboplatin and Taxol At least 6 patients will be entered onto each dose level Doses will not be escalated over the course of treatment of an individual patient The recommended Phase II dose is defined as the highest dose of bexarotene oral capsules 300 mgm2 or 400 mgm2 in combination with carboplatin and Taxol that induces DLT in fewer than or equal to 33 of patients
The sequential phase II portion of the study will evaluate the efficacy of bexarotene oral capsules in combination with carboplatin and weekly Taxol in patients with advanced non-small cell lung cancer The efficacy will be gauged according to the rate of major response where by definition a major response occurs if a patient achieves either complete remission CR or partial remission PR For these patients a true response rate of 20 or greater is sufficiently large to warrant further investigation A true response rate of 10 or less indicates that the combination is less active
The sequential phase II portion of the study will evaluate the efficacy of bexarotene oral capsules in combination with carboplatin and weekly Taxol in patients with advanced non-small cell lung cancer The efficacy will be gauged according to the rate of major response where by definition a major response occurs if a patient achieves either complete remission CR or partial remission PR For these patients a true response rate of 20 or greater is sufficiently large to warrant further investigation A true response rate of 10 or less indicates that the combination is less active
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