Expired Study
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Bethesda, Maryland 20892


Purpose:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of inhaled doxorubicin in treating patients who have advanced solid tumors affecting the lungs.


Study summary:

OBJECTIVES: - Determine the maximum tolerated dose and phase II dose of inhaled doxorubicin in patients with advanced solid tumors affecting the lungs. - Determine the toxicity of this regimen in these patients. - Determine the pharmacokinetic profile of inhaled doxorubicin in blood in these patients. - Determine the relationship between pharmacodynamic parameters and toxic effects of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients receive inhaled doxorubicin every 3 weeks for up to 3 doses. Patients with stable or responding disease may receive additional doses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of doxorubicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 3 weeks and 3 months. PROJECTED ACCRUAL: Approximately 33 patients will be accrued for this study within 18-24 months.


Criteria:

DISEASE CHARACTERISTICS: - Histologically proven advanced cancer not curable by standard chemotherapy, radiotherapy, or surgery - Clinical evidence of primary lung or tracheal cancer OR - Metastatic cancer to the lung - Extrathoracic metastases eligible if following criteria are met: - Sites are stable - Pulmonary sites are primary life-threatening sites - Evidence that study treatment may benefit the patient - Measurable or evaluable disease - No germ cell tumor, leukemia, or lymphoma involving the lungs that is treatable with systemic agents - No complete atelectasis due to high-grade airway obstruction PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - More than 3 months Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 g/dL Hepatic: - Bilirubin no greater than 1.0 mg/dL - AST and ALT less than 1.5 times upper limit of normal Renal: - Creatinine no greater than 1.6 mg/dL OR - Creatinine clearance at least 60 mL/min Cardiovascular: - LVEF at least 40% by MUGA scan or echocardiogram - No unstable angina, congestive heart failure, or symptomatic arrhythmias Pulmonary: - DLCO at least 50% predicted - FVC and FEV1 at least 50% predicted - Resting oxygen saturation at least 90% - Exercise oxygen saturation at least 85% - Oxygen consumption greater than 50% predicted - No prior radiation pneumonitis - No asthma - No radiation-induced pulmonary damage Other: - No hypersensitivity to doxorubicin - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 6 months after study - HIV negative - No congenital problems (e.g., cleft palate) or other anomalies that prevent tight fit of a mouthseal PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior biologic therapy and recovered - No prior trastuzumab (Herceptin) Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior chemotherapy and recovered - Prior doxorubicin allowed if LVEF at least 40% by MUGA scan or echocardiogram - No prior mitomycin, bleomycin, or nitrosoureas - No other concurrent systemic chemotherapy Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy and recovered - At least 12 months since prior radiotherapy to chest - No prior radiotherapy to more than 20% of total lung volume - Prior chest wall or primary breast radiotherapy allowed - Prior radioactive iodine allowed - No concurrent thoracic radiotherapy Surgery: - See Disease Characteristics - No prior total pneumonectomy Other: - No other concurrent experimental drug


NCT ID:

NCT00020124


Primary Contact:

Study Chair
David S. Schrump, MD
NCI - Surgery Branch


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

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