Inhaled Doxorubicin Plus IV Docetaxel and Cisplatin in Patients With Non-Small-Cell Lung Carcinoma (NSCLC)

NCT00082472 | Unknown Phase 1

• 1 other identifier: Dox-2a-07
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 6

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.

Conditions

NSCLC

Keywords

NSCLC; Metastatic; Unresectable; No Prior Chemotherapy

Interventions

Doxorubicin HCl Inhalation Solution DRUG

Docetaxel DRUG

Cisplatin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Zivena: lead

Study Sites (6)

Yale University Cancer Center

New Haven, Connecticut, 06520, United States

Location

Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Nevada Cancer Institute

Las Vegas, Nevada, 89135, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Arthur G James Cancer Hospital and Richard Solove Research Institute at Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Wisconsin Cancer Center

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Docetaxel; Cisplatin

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 11, 2004
• First Posted: May 12, 2004
• Study Start: January 1, 2004
• Last Updated: April 18, 2006

Record last verified: 2006-04

Locations

US (6)