Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00193596
Status:
COMPLETED
Last Update Posted:
2013-05-03
First Post:
2005-09-12
Brief Title:
GemcitabineIrinotecanZD1839 vs PaclitaxelCarboplatinEtoposideZD1839 in Carcinoma of Unknown Primary Site
Sponsor:
SCRI Development Innovations LLC
Organization:
SCRI Development Innovations LLC
Study Overview
Official Title:
A Randomized Phase III Comparison of GemcitabineIrinotecan Followed by IRESSA Versus PaclitaxelCarboplatinEtoposide Followed by IRESSA in the First-Line Treatment of Patients With Carcinoma of Unknown Primary Site
Status:
COMPLETED
Status Verified Date:
2013-03
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:
In this randomized trial we will investigate the activity and toxicity of two active regimens gemcitabineirinotecan and paclitaxelcarboplatinEtoposide both followed by ZD1839 in the first-line treatment of patients with carcinoma of unknown primary site
Detailed Description:
Upon determination of eligibility all patients will be randomly assigned to one of two treatment arms
Paclitaxel Carboplatin Etoposide
Irinotecan Gemcitabine
Patients will be stratified by tumor location liverbone versus all others and number of metastatic sites one versus two or more Patients with an objective response or stable disease after completion of chemotherapy will receive ZD1839 until disease progression Patients who do not respond to chemotherapy may crossover to the other chemotherapy regimen and will receive ZD1839 if they have an objective response or stable disease The study is not blinded so both the patient and the doctor will know which treatment has been assigned
Paclitaxel Carboplatin Etoposide
Irinotecan Gemcitabine
Patients will be stratified by tumor location liverbone versus all others and number of metastatic sites one versus two or more Patients with an objective response or stable disease after completion of chemotherapy will receive ZD1839 until disease progression Patients who do not respond to chemotherapy may crossover to the other chemotherapy regimen and will receive ZD1839 if they have an objective response or stable disease The study is not blinded so both the patient and the doctor will know which treatment has been assigned
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