Inhaled Doxorubicin Plus IV Docetaxel and Cisplatin in Patients With Non-Small-Cell Lung Carcinoma (NSCLC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00082472|
Recruitment Status : Unknown
Verified April 2006 by Zivena.
Recruitment status was: Active, not recruiting
First Posted : May 12, 2004
Last Update Posted : April 18, 2006
|Condition or disease||Intervention/treatment||Phase|
|NSCLC||Drug: Doxorubicin HCl Inhalation Solution Drug: Docetaxel Drug: Cisplatin||Phase 1 Phase 2|
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.
- To define the nature of the toxic effects of inhaled doxorubicin when given in combination with IV docetaxel and cisplatin.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Inhaled Doxorubicin Plus IV Docetaxel and Cisplatin in Patients With Locally Advanced or Metastatic Unresectable Non Small Cell Lung Cancer|
|Study Start Date :||January 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00082472
|United States, Connecticut|
|Yale University Cancer Center|
|New Haven, Connecticut, United States, 06520|
|United States, Nevada|
|Southern Nevada Cancer Research Foundation|
|Las Vegas, Nevada, United States, 89106|
|Nevada Cancer Institute|
|Las Vegas, Nevada, United States, 89135|
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10461|
|United States, Ohio|
|Arthur G James Cancer Hospital and Richard Solove Research Institute at Ohio State University|
|Columbus, Ohio, United States, 43210|
|United States, Wisconsin|
|University of Wisconsin Cancer Center|
|Madison, Wisconsin, United States, 53792|