COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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. 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
Information provided by:

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.

Condition or disease Intervention/treatment Phase
NSCLC Drug: Doxorubicin HCl Inhalation Solution Drug: Docetaxel Drug: Cisplatin Phase 1 Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologic or cytologic proof of locally advanced or metastatic unresectable NSCLC, Patients with the pneumonic form of BAC, or cavitary lesions > 3.5 cm or with cavitary lesions of any size with air/fluid levels are not eligible.
  • No prior chemotherapy or biologic therapy for lung cancer
  • Measurable or evaluable pulmonary disease required
  • Age > 18 years
  • ECOG performance status of 0-1
  • Adequate bone marrow, hepatic, and renal function
  • Total bilirubin < ULN
  • SGOT and/or SGPT may be up to 2.5 x ULN if alkaline phosphatase is ≤ ULN, or alkaline phosphatase may be up to 4 x ULN if SGOT and SGPT are both ≤ ULN
  • Creatinine <1.5 mg/dL or creatinine clearance > 60 mL/min/1.7 m2 BSA
  • Patients must have the following pulmonary function test values:

    • DLCO > 50% predicted. (DLCO must be adjusted for the patient's hemoglobin)
    • FVC> 50% of predicted
    • FEV1 >50% of predicted
    • Resting oxygen saturation > 90%
    • Exercise oxygen saturation > 85%
  • Prior surgery is permitted provided full recovery has occurred
  • Patients may not have received prior radiotherapy to the lungs. Patients with only chest wall or breast irradiation are eligible provided there is no radiographic evidence of pulmonary damage attributed to radiation therapy. Patients who have undergone Radioactive Iodine (RAI) therapy are also eligible.
  • Patients must sign an informed consent indicating that they are aware of the investigational nature of this study.

Exclusion Criteria:

  • 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
  • asthma
  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00082472

Layout table for location information
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
Sponsors and Collaborators
Layout table for additonal information Identifier: NCT00082472    
Other Study ID Numbers: Dox-2a-07
First Posted: May 12, 2004    Key Record Dates
Last Update Posted: April 18, 2006
Last Verified: April 2006
Keywords provided by Zivena:
No Prior Chemotherapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Liposomal doxorubicin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors