Inhaled Doxorubicin in Treating Patients With Advanced Solid Tumors Affecting the Lungs

NCT00020124 | Completed Phase 1

• 3 other identifiers: 00008800-C-0088CDR0000067718
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer; Malignant Mesothelioma; Metastatic Cancer

Keywords

recurrent non-small cell lung cancer; extensive stage small cell lung cancer; recurrent small cell lung cancer; advanced malignant mesothelioma; recurrent malignant mesothelioma; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; pulmonary carcinoid tumor; lung metastases

Interventions

doxorubicin hydrochloride DRUG

Eligibility Criteria

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Mesothelioma, Malignant; Neoplasm Metastasis; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Interventions

Doxorubicin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Mesothelial; Pleural Neoplasms; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• David S. Schrump, MD

  NCI - Surgery Branch

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 11, 2001
• First Posted: January 27, 2003
• Study Start: June 1, 2000
• Study Completion: December 1, 2002
• Last Updated: March 15, 2012

Record last verified: 2012-03

Locations

US (1)