Spots Global Cancer Trial Database for Inhaled Doxorubicin Plus IV Docetaxel and Cisplatin in Patients With Non-Small-Cell Lung Carcinoma (NSCLC)

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Trial Identification

Brief Title: Inhaled Doxorubicin Plus IV Docetaxel and Cisplatin in Patients With Non-Small-Cell Lung Carcinoma (NSCLC)

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 ID: NCT00082472

Conditions

NSCLC

Interventions

Doxorubicin HCl Inhalation Solution

Docetaxel

Cisplatin

Study Description

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.