Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00082472
Status:
UNKNOWN
Last Update Posted:
2006-04-18
First Post:
2004-05-11
Brief Title:
Inhaled Doxorubicin Plus IV Docetaxel and Cisplatin in Patients With Non-Small-Cell Lung Carcinoma NSCLC
Sponsor:
Zivena
Organization:
Zivena
Study Overview
Official Title:
Phase III Study of Inhaled Doxorubicin Plus IV Docetaxel and Cisplatin in Patients With Locally Advanced or Metastatic Unresectable Non Small Cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2006-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is intended to show whether inhaled chemotherapy can be added to a standard IV chemotherapy regime to investigate the additional toxicities and to show initial evidence of efficacy of the combination
Detailed Description:
Primary Objective of Phase I
To determine the maximal and Phase II dose of inhaled doxorubicin HCl when given in combination with IV docetaxel and cisplatin in patients with locally advanced or metastatic unresectable NSCLC who have not been previously treated with chemotherapy
Primary Objective of Phase II
To obtain preliminary evidence of therapeutic activity using imaging studies in patients with measurable or evaluable lung lesions and serial measurements of disease-related pulmonary symptoms and pulmonary function
Secondary Objective
To define the nature of the toxic effects of inhaled doxorubicin when given in combination with IV docetaxel and cisplatin
To determine the maximal and Phase II dose of inhaled doxorubicin HCl when given in combination with IV docetaxel and cisplatin in patients with locally advanced or metastatic unresectable NSCLC who have not been previously treated with chemotherapy
Primary Objective of Phase II
To obtain preliminary evidence of therapeutic activity using imaging studies in patients with measurable or evaluable lung lesions and serial measurements of disease-related pulmonary symptoms and pulmonary function
Secondary Objective
To define the nature of the toxic effects of inhaled doxorubicin when given in combination with IV docetaxel and cisplatin
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