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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00082472
Other study ID # Dox-2a-07
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received May 11, 2004
Last updated April 14, 2006
Start date January 2004

Study information

Verified date April 2006
Source Zivena
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Doxorubicin HCl Inhalation Solution

Docetaxel

Cisplatin


Locations

Country Name City State
United States Montefiore Medical Center Bronx New York
United States Arthur G James Cancer Hospital and Richard Solove Research Institute at Ohio State University Columbus Ohio
United States Nevada Cancer Institute Las Vegas Nevada
United States Southern Nevada Cancer Research Foundation Las Vegas Nevada
United States University of Wisconsin Cancer Center Madison Wisconsin
United States Yale University Cancer Center New Haven Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Zivena

Country where clinical trial is conducted

United States, 

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