Clinical trial · Interventional
Inhaled Doxorubicin in Treating Patients With Advanced Solid Tumors Affecting the Lungs
Phase I and Clinical Pharmacologic Study of Inhaled Doxorubicin in Adults With Advanced Solid Tumors Affecting the Lungs
NCT00020124CI-TRIAL-00006485completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Malignant Mesothelioma | Malignant Mesothelioma | ONTOLOGY_EXACT | 0.98 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.