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Inhaled Doxorubicin Plus IV Docetaxel and Cisplatin in Patients with Non-Small-Cell Lung Carcinoma (NSCLC) Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Inhaled Doxorubicin Plus IV Docetaxel and Cisplatin in Patients with Non-Small-Cell Lung Carcinoma (NSCLC) conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Inhaled Doxorubicin Plus IV Docetaxel and Cisplatin in Patients with Non-Small-Cell Lung Carcinoma (NSCLC) Clinical research trials and Inhaled Doxorubicin Plus IV Docetaxel and Cisplatin in Patients with Non-Small-Cell Lung Carcinoma (NSCLC) healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Inhaled Doxorubicin Plus IV Docetaxel and Cisplatin in Patients with Non-Small-Cell Lung Carcinoma (NSCLC). Inhaled Doxorubicin Plus IV Docetaxel and Cisplatin in Patients with Non-Small-Cell Lung Carcinoma (NSCLC) Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Inhaled Doxorubicin Plus IV Docetaxel and Cisplatin in Patients with Non-Small-Cell Lung Carcinoma (NSCLC) clinical trial. Subjects frequently obtain the most expert healthcare possible for their Inhaled Doxorubicin Plus IV Docetaxel and Cisplatin in Patients with Non-Small-Cell Lung Carcinoma (NSCLC) condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Inhaled Doxorubicin Plus IV Docetaxel and Cisplatin in Patients with Non-Small-Cell Lung Carcinoma (NSCLC)  Inhaled Doxorubicin Plus IV Docetaxel and Cisplatin in Patients with Non-Small-Cell Lung Carcinoma (NSCLC)
Inhaled Doxorubicin Plus IV Docetaxel and Cisplatin in Patients with Non-Small-Cell Lung Carcinoma (NSCLC)
For Condition: NSCLC
Status: Recruiting
Sponsor(s): Zivena ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 30
Location and Contact Information:
Montefiore Medical Center *Recruiting*
Bronx, New York, 10461
United States
Recruiting Missak Haigentz
University of Wisconsin Cancer Center *Recruiting*
Madison, Wisconsin, 53792
United States
Recruiting Joan Schiller
Southern Nevada Cancer Research Foundation *Recruiting*
Las Vegas, Nevada, 89106
United States
Recruiting John Ellerton
Nevada Cancer Institute *Recruiting*
Las Vegas, Nevada, 89135
United States
Recruiting John Murren
Yale University Cancer Center *Recruiting*
New Haven, Connecticut, 06520
United States
Recruiting John Murren
Arthur G James Cancer Hospital and Richard Solove Research Institute at Ohio State University *Recruiting*
Columbus, Ohio, 43210
United States
Recruiting Gregory Otterson
Additional Information:
Study ID Numbers: Dox-2a-07;
Study Start Date: January 2004
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00082472
Other Nsclc Studies:
1. Inhaled Doxorubicin Plus IV Docetaxel and Cisplatin in Patients with Non-Small-Cell Lung Carcinoma (NSCLC)
2. Phase II Study of Taxotere in Combination with Exisulind in Non-Small Cell Lung Cancer (NSCLC) Patients
Related Studies:
Other NSCLC Clinical Trials
Other Nevada Clinical Trials
Other Las Vegas Clinical Trials
Inhaled Doxorubicin Plus IV Docetaxel and Cisplatin in Patients with Non-Small-Cell Lung Carcinoma (NSCLC)
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