Clinical trial · Interventional
Inhaled Doxorubicin in Treating Patients With Primary Lung Cancer or Lung Metastases
Phase I and Clinical Pharmacologic Study of Inhaled Doxorubicin in Adults With Advanced Solid Tumors Affecting the Lungs
NCT00004930CI-TRIAL-00010805completedPhase 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. PURPOSE: Phase I trial to study the effectiveness of inhaled doxorubicin in treating patients who have primary lung cancer or lung metastases.
Conditions
Conditions (2)
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 |
| 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 confirmed primary lung cancer or cancer metastatic to the lung that is not potentially curable by standard chemotherapy, radiotherapy, or surgery * Bronchoalveolar cell lung cancer allowed * Lung metastases from soft tissue sarcoma allowed * No leukemia or lymphoma PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 70-100% Life expectancy: * Not specified Hematopoietic: * WBC at least 4,000/mm\^3 * Platelet count at least 160,000/mm\^3 * Hemoglobin at least 9 g/dL Hepatic: * Bilirubin no greater than 1.0 mg/dL * AST/ALT less than 1.5 times upper limit of normal Renal: * Creatinine no greater than 1.2 mg/dL OR * Creatinine clearance at least 50 mL/min Cardiovascular: * LVEF normal by MUGA scan or echocardiography * No unstable angina * No congestive heart failure * No symptomatic arrhythmias Pulmonary: * DLCO at least 65% of normal * FVC at least 50% predicted * FEV1 at least 50% predicted * Resting oxygen saturation at least 90% * Exercise oxygen saturation at least 85% * No complete atelectasis * No asthma Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study * No congenital problems (e.g., cleft palate) or other anomalies that would prevent tight fit of mouth seal * No other concurrent illness that would preclude study therapy PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * At least 3 weeks since prior chemotherapy and recovered * No prior bleomycin or nitrosoureas * No prior mitomycin greater than 25 mg/m\^2 * No prior anthracyclines greater than 450 mg/m\^2 * No other concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * At least 3 weeks since prior radiotherapy and recovered * No prior chest (pulmonary or mediastinal) or thoracic spine radiotherapy * Patients with only chest wall or primary breast radiation are eligible * No concurrent thoracic irradiation Surgery: * See Disease Characteristics * No prior pneumonectomy Other: * No daily or as necessary respiratory drugs via inhaler or nebulizer * No other concurrent experimental drugs
References
Publications (0)
Data not yet available
No reference posted for this study.