Inhaled Doxorubicin Plus IV Docetaxel and Cisplatin in Patients With Non-Small-Cell Lung Carcinoma (NSCLC)
NCT ID: NCT00082472
Last Updated: 2006-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2004-01-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Doxorubicin HCl Inhalation Solution
Docetaxel
Cisplatin
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Zivena
INDUSTRY
Locations
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Yale University Cancer Center
New Haven, Connecticut, United States
Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States
Nevada Cancer Institute
Las Vegas, Nevada, United States
Montefiore Medical Center
The Bronx, New York, United States
Arthur G James Cancer Hospital and Richard Solove Research Institute at Ohio State University
Columbus, Ohio, United States
University of Wisconsin Cancer Center
Madison, Wisconsin, United States
Countries
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Other Identifiers
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Dox-2a-07
Identifier Type: -
Identifier Source: org_study_id