NSCLC Clinical Trial
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
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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