Inhaled Doxorubicin Plus IV Docetaxel and Cisplatin in Patients With Non-Small-Cell Lung Carcinoma (NSCLC)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2006 by Zivena.
Recruitment status was Active, not recruiting
Information provided by:
First received: May 11, 2004
Last updated: April 14, 2006
Last verified: April 2006
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.
Drug: Doxorubicin HCl Inhalation Solution
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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:
| Study Start Date:
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Women must not be pregnant or breast-feeding during this study. Men and women with reproductive potential must use an effective contraceptive method while on this study and agree to use an effective method for three months after completing chemotherapy.
- Patients with large obstructive pulmonary lesions that may cause blockage of delivery of aerosolized drug to the affected lung, in the judgment of the treating physician. A ventilation scan is recommended if the status is unclear.
- Patients with other active malignancies. Patients with a history of prior malignancy other than NSCLC must not have received chemotherapy within the past 5 years and may not have had prior therapy with mitomycin (> 25 mg/m2), bleomycin or nitrosoureas (> 200 mg/m2). The patient may not have had any indication of pulmonary toxicity from the chemotherapy.
- Serious active infections which are not controlled such that the patient continues to manifest symptoms despite treatment
- Patients with progressive extra-pulmonary metastases who are unlikely to benefit from systemic or inhaled chemotherapy, e.g., extensive liver metastases, untreated brain metastases or treated brain metastases which are not clinically stable. If patients have received radiation treatment for brain metastases, at least 3 weeks must have elapsed since the last treatment and the patient must have recovered from all toxicity, not be receiving corticosteroids and have stable neurologic function off corticosteroids.
- Patients with known hypersensitivity to platinum compounds or taxanes or other drugs formulated with polysorbate 80
- uncontrolled diabetes mellitus
- Patients who have undergone lung transplantation
- unstable angina, congestive heart failure, or symptomatic arrhythmias or any other serious illness or medical condition that in the judgment of the investigator compromises the patient’s safety
- clinically significant neuropathy (≥ Grade 1) by history or physical examination
- Patients using other investigational drugs
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00082472
|Yale University Cancer Center
|New Haven, Connecticut, United States, 06520 |
|Nevada Cancer Institute
|Las Vegas, Nevada, United States, 89135 |
|Southern Nevada Cancer Research Foundation
|Las Vegas, Nevada, United States, 89106 |
|Montefiore Medical Center
|Bronx, New York, United States, 10461 |
|Arthur G James Cancer Hospital and Richard Solove Research Institute at Ohio State University
|Columbus, Ohio, United States, 43210 |
|University of Wisconsin Cancer Center
|Madison, Wisconsin, United States, 53792 |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 11, 2004
||April 14, 2006
||United States: Food and Drug Administration
Keywords provided by Zivena:
No Prior Chemotherapy
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 09, 2015
Carcinoma, Non-Small-Cell Lung
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Molecular Mechanisms of Pharmacological Action
Topoisomerase II Inhibitors