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Sponsored by: |
Zivena |
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Information provided by: | Zivena |
ClinicalTrials.gov Identifier: | NCT00082472 |
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.
Condition | Intervention | Phase |
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NSCLC |
Drug: Doxorubicin HCl Inhalation Solution Drug: Docetaxel Drug: Cisplatin |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 30 |
Study Start Date: | January 2004 |
Primary Objective of Phase I
Primary Objective of Phase II
Secondary Objective
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have the following pulmonary function test values:
Exclusion Criteria:
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 |
Study ID Numbers: | Dox-2a-07 |
Study First Received: | May 11, 2004 |
Last Updated: | April 14, 2006 |
ClinicalTrials.gov Identifier: | NCT00082472 History of Changes |
Health Authority: | United States: Food and Drug Administration |
NSCLC Metastatic Unresectable No Prior Chemotherapy |
Thoracic Neoplasms Doxorubicin Carcinoma Docetaxel Anti-Bacterial Agents Respiratory Tract Diseases Cisplatin |
Radiation-Sensitizing Agents Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Pharmacologic Actions Doxorubicin Carcinoma Docetaxel |
Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Respiratory Tract Diseases Cisplatin Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |